Showing posts with label Recall. Show all posts
Showing posts with label Recall. Show all posts

Sunday, May 8, 2022

Pfizer: Blood Pressure Medication Recalled due to exceeding allowable level of Cancer-Causing Impurities (March 2022)

Case Controversy

Pfizer is an extremely recognizable company, founded in 1849 by Charles Pfizer and his cousin Charles Erhart. Pfizer was most recently in the news during the COVID-19 epidemic, as it was one of 3 major medical companies to formulate a vaccine against the virus. In March 2022, however, Pfizer issued a voluntary recall of several lots of different blood pressure medication including Accuretic (quinapril HCl/hydrochlorothiazide) tablets as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide). Greenstone, a wholly owned subsidiary of Pfizer, produces several other generics of other medications for Pfizer.

Accuretic, as well as its corresponding authorized genetics distributed by Greenstone, is a set of medications used to treat high blood pressure, or hypertension. Currently, it is unknown whether it is safe or effective in children under the age of 18, however, high blood pressure is typically a result of a long-term diet high in fats, salt, and/or cholesterol. Although high blood pressure can be genetic, it is unlikely to require medication at age 18 or earlier. Its empirical formula is C25H30N2Oand its structural formula is as seen in Figure 1.

The March 2022 recall was issued for a total of 6 Accuretic tablet lots consisting of 3 different configurations (10/12.5 mg, 20/12.5 mg, and 20/25 mg) as well as one lot of quinapril and hydrochlorothiazide tablets (20/25 mg) and four lots of quinapril HCl/ hydrochlorothiazide tablets consisting of 2 configurations (20/12.5 mg and 20/25 mg). These medications were distributed between November 2019 to March 2022 and were set to expire between April 2022 and August 2024. Pfizer provided the affected lot numbers as well as the NDC’s, expiration dates, and configurations for each of the affected medications on their website.

The company released a statement on their website stating that they are issuing a volunteer recall of these specific lots of medications at “the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level”. Nitrosamines are an impurity caused by the chemical reactions of nitrites or nitrates with specific amines. Nitrosamines are not an impurity that is specific to medications. They are found within everyday consumer products including processed meats, alcoholic beverages, cosmetics, and cigarette smoke, meaning everyone is subjected to some level of nitrosamine intake. These impurities are known to lead to an increased risk in cancer if they are ingested above the acceptable daily intake level for long periods of time. Equivalently, the FDA also claims that someone ingesting medication daily at or below the acceptable daily intake level for 70 years is not expected to have any increase in cancer risk. Interestingly the FDA website states that medications found to have nitrosamine levels above the acceptable daily intake level are “recommend[ed] these drugs be recalled by the manufacturer as appropriate”, however, it is not mandatory.

When the recall was first issued, the FDA released a statement stating that “to date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.” This makes sense, as the effects of nitrosamines are not proven to have any imminent threat to life, as cancers typically develop over time due to extended over-intake. In addition, Pfizer also pointed out that their hypertension medication has a “safety profile that has been established over 20 years of marketing authorization and through a robust clinical program.” Interestingly, the FDA advises patients that are currently taking prescription medications with potential nitrosamine impurities to continue taking their medication and contact their health provider about potential concerns and other treatment options. As of the date of the initial statement release, the source of the impurities is unknown, however the agency is said to be working on determining the source and claims they will “keep the public informed”.



Stakeholders

The stakeholders in this particular case would include the Manufacturers, Current Patients, Doctor’s prescribing these medications, Future Shareholders, Future Patients, and the General Public. The future success of the company is dictated by the actions they take based on the guidelines the Food and Drug Administration provides them. Pfizer’s actions also dictate what the manufacturers of these drugs will do. The current patients who need these blood pressure medications may or may not be affected depending on if they have been on if they have been taking the medication long-term or not. The doctors who are prescribing these medications to their patients are affected by this recall because now they have to consult with all of their patients and figure out what treatment to give them now. The future shareholders are affected because what the FDA’s testing and analysis on these medications and the classification that organization gives for the drugs can alter the future value of the company’s stock once the results of the recall are released. Future patients are affected because of the medications being off the market, patients will have to seek prescriptions from other brands. The general public is affected because Pfizer’s medications are distributed all across the nation. 

Individualism

According to Dr. Salazar, a professor of philosophy at Western New England University, under Individualism, business actions should maximize profits for the owners of a business but do so within the law.  Dr. Salazar also states that, “Both versions of this theory are grounded in the responsibility of a business to its owner or owners, whether they are individual people or the stockholders of a publicly-traded company”. So, an individualist would say that Pfizer recalling their blood pressure medication is not the most ethically beneficial. In Pfizer’s case, profit was not maximized for the owner which we can see when doing further analysis of the stakeholders as the following:

Manufactures: The manufactures will negatively impact the profit for the owners of the company. Because of the recall, the manufacturers of these blood pressure medications are forced to stop making these drugs. They cannot do anything until the company receives guidelines from the FDA. Therefore, none of the blood pressure medications will be able to be sold on the market and be able to make any profit off of these prescription drugs.

Current Patients: The current patients will negatively impact the profit for the owners of the company. Because of the recall, the current patients will stop taking these medications and seek a different treatment with their healthcare provider. Therefore, the company will have to lose all of their customers that purchase and consume these medications. Therefore, the owner of the company will lose money.

The Doctors: The doctors prescribing these medications to their patients will negatively impact the profit for the owners of the company. Now that these medications are being recalled and are off the market, doctors will now consult with their patients and prescribe a different treatment. Therefore, the owner of the company will lose money.

Future Shareholders: Future shareholders who want to invest in a company will also negatively affect future profits for the owner of the company. Because of the recall and the blood pressure medication being off the market, customers will lose money and there is no certainty that these blood pressure medications from Pfizer will go back in the market.  This will decrease the value of the company and its stock price which will not attract investors.

Future Patients: The future patients will negatively impact the future profit for the owners of the company. Because the company had to recall their blood pressure medication, future patients will be prescribed blood pressure medications from different companies by their healthcare provider.

The General Public:  The general public will negatively impact the profit for the owners of the company. The general public expects pharmaceutical companies like Pfizer to come out with prescription drugs that are safe to consume. The general public will have a hard time trusting the company which will not help the owner make money.

It is obvious that Pfizer’s recall of their blood pressure medications was not ethical in an individualist’s perspective and that profit was not maximized for the company. The company has done recalls in the past and had to take certain drugs off the market, and they followed the guidelines set by the FDA. Therefore, the next step that Pfizer takes when it comes to their blood pressure medication will depend on what the FDA’s testing and analysis on these medications and the classification that organization gives for the drugs.

Utilitarianism

The main ideas surrounding utilitarianism focus on maximizing happiness and well-being equally for all parties involved.  The theory of utilitarianism states that actions are right insofar as they produce happiness but wrong if they promote unhappiness.  The theory also includes the idea that happiness and pleasure are the only thing that truly has intrinsic value.  In terms of the case controversy under the scope of utilitarianism, Pfizer attempted to maximize happiness for all parties involved and well-being equally.  Unfortunately, due to the lack of information provided by Pfizer as to when they became aware of these potentially harmful findings, it cannot be said for sure whether or not they have partaken in unethical practices. However, Pfizer voluntarily recalled their own medication; despite the negative effects it could have on the corporation financially and its reputation.  They included information on why the blood pressure medication was being recalled so as to inform both the public and patients prescribed the drug.  They also provided contact information and instructions on how to return the recalled lots and receive reimbursement for their costs.  Despite being a major pharma corporation, they put the happiness and well-being of their patients at the forefront by voluntarily recalling their medication, providing the proper information, and assuring patients of reimbursements.  They also maximize their own happiness and well-being by getting ahead of the recall and maintaining their reputation and status.  Pfizer is not financially responsible for the repercussions of taking the medication as they informed their patients and voluntarily recalling their drug before there were any cases reported.  Since the adverse effects of taking the medication are not immediate but rather occur after having large doses over an extended period of time, reporting their findings before anything bad had happened maximizes the happiness of both the corporation and patient. The stakeholders involved are affected under the scope of utilitarianism ethics as follows: 

Pfizer Manufacturers/Employees:  Pfizer voluntarily recalled their high blood pressure medication, Accuretic, because the levels of nitrosamines present were above the acceptable daily intake (ADI).  Both the manufacturers and employees of Pfizer are maximizing their happiness this way as they allow themselves to have a clear conscience as there have been no reported cases of detrimental impacts from the medication to patients.  They also maintain their company’s reputation by voluntarily recalling the drug rather than leaving it on the market to maximize profits which creates good will with their patients.  The information provided by Pfizer in regards to disposal of the affected lots and reimbursement for the patients fosters a sense of trust between the pharmaceutical corporation and its patients, in turn maximizing the happiness of Pfizer as they do not lose customers. The employees and manufacturers will also be working towards fixing the problem and ensuring it does not happen in the future, which will create more profit in the long run, ultimately maximizing their happiness.

Pfizer shareholders:  With the voluntary recall of the blood pressure medication, Pfizer shareholders are reassured that Pfizer is not financially liable for any adverse effects, and therefore maintains a positive reputation and avoids potential lawsuits which could be greatly detrimental to the company’s stock price.  By voluntarily recalling the medication and providing information and outlets to current patients, the stock price should not waiver as the company has numerous different streams of revenue not directly related to the recall and conveys that they hold the shareholders’ and consumers’ happiness at the highest regard.  This maximizes the happiness of the shareholders as the company maintains a good reputation and their social consciousness will be appealing to potential future investors which will have a positive impact on the stock price.

Doctors/Pharmacists:   The voluntary recall of the blood pressure medication by Pfizer also maximizes the happiness of doctors and pharmacists as they clear the conscience of guilt that would be had by continuing to prescribe and sell potentially tainted lots.  Due to the recall, there will be more interaction between patients and their doctors/pharmacists which will promote more business.  Doctors will meet more with patients to discuss alternative routes for medication which creates more profit and pharmacists will be selling more blood pressure medications which promotes more business, conclusively maximizing their happiness.

Patients:  Current patients of the high blood pressure medication are perhaps the most affected by this situation as they must find out whether or not they hold any of the tainted lots of the medication.  According to a study conducted by the analytics company IQVIA, there were approximately 1,300 patients using Accuretic in 2020 and another 192,000 users of the generic forms. However, they are reassured by the fact that there have been no reported cases of adverse effects and the information that these effects only occur after an extended period of use in high doses.  By Pfizer voluntarily recalling its medication, the patient is made aware of the problem and takes comfort in knowing the corporation holds its patients health in the highest regard.  Pfizer also provides information for the patient to determine whether or not they have an affected lot of the medication and urges them to contact their medical provider with any questions.  By doing this, the patients’ happiness is maximized as they are given the knowledge voluntarily and are promised reimbursement for any tainted lot as well.

It is clear that Pfizer’s voluntary recall of their blood pressure medication was an ethical act under utilitarianism made to maximize the happiness of all parties involved.  By recalling the medication voluntarily, Pfizer ensures a sense of trust between them, their shareholders, doctors/pharmacists, and their patients by a way of honesty and transparency.  They also provide avenues and reassurances for all parties which aims to maximize the happiness of each.

Kantianism

Pfizer voluntarily recalled their blood pressure medication due to the potential cancer-causing impurities. This way of handling the situation from a Kantian point of view was most definitely the most ethically beneficial for almost everyone involved. The center of Kantian ethics is based on goodwill. Goodwill is defined as the “rationality which chooses to do what is right for the reason it is good” (Salazar 4). In addition, an important aspect of Kantian ethics is Kant’s formulation of humanity. The formulation of humanity can be described as requiring humans “never to treat others merely as a means to an end, but always as ends in themselves.” This means that a business's customers are not used in achieving a particular “end” but rather treated as an end in themselves. The Kantian ethical view also entails acting with respect to all autonomous human beings. This means doing what’s morally right by the people you serve and doing it for the right intentions. In addition, Kantian ethics is reliant on the duty to do right while respecting a person’s moral rights. In this case, Pfizer acted with the duty to protect the well being of its customers while respecting their right to contact their doctor if they would like to change their medication or treatment plan. In Pfizer’s case, all of the stakeholder’s health and safety were prioritized and the well being of the customers were maximized. Ethically, each stakeholder was affected as follows:

High Blood Pressure Patients: The group of people most directly benefiting from the recall are the patients suffering from hypertension. The company issued the recall due to the well being of the patients. As the FDA’s website states, the company is recommended, but not obligated, to recall medications exceeding the acceptable daily intake levels. By Pfizer voluntarily recalling the medication shows they have acted with the goodwill of the consumer in mind, directly demonstrating what Kantian ethics is all about.

Pfizer Shareholders: Due to Pfizer’s immediate response with the thought of the customer in mind, Pfizer shareholders should benefit. Stocks should hold steady with the public knowing that the company always has the best interest of the consumer in mind. These holders indirectly benefit from Pfizer’s handling of the situation as any company who has the best interest of the consumer automatically becomes more attractive for current and future investors.

Doctors: Medical personnel can also indirectly benefit from the situation as they will have an influx of customers needing a new prescription of the contaminated drug. More business is always a good thing for anyone who is getting paid for it.

Manufacturers/Employees: These employees benefit most nearly in a similar way as the doctors. They get an influx in more work as they must continue to closely monitor the Pfizer distribution operation. They also have more work to try to find the source of the impurities themselves. This will help to ensure similar problems in the future do not occur. Due to the employees getting more work and paying even closer attention, it also improves the wellbeing of future hypertension patients as it is less likely that impure medications from Pfizer will make it out of distribution.

It is clear that Pfizer acted in the goodwill of the consumer, which, in turn, benefited all the stakeholders either directly or indirectly. Acting in the goodwill of the customer aligns concurrently with the Kantian ethical point of view. Pfizer acted swiftly and morally right which benefited everyone involved.

Virtue Theory

Looking at this case from the ethical beliefs within the Virtue Theory, Pfizer acted in an ethically correct way by recalling their contaminated products. The Virtue Theory was developed in the 4th century BC by Aristotle, a well known philosopher of the time and still to this day. This theory consisted of 4 important characteristics: courage, self-control/temperance, honesty, and fairness. Aristotle developed this theory to help his followers distinguish right from wrong. Virtue is attained by setting your eyes on a purpose and doing what is morally right to achieve that purpose. All 4 main characteristics of virtue theory are displayed with respect to each stakeholder. Each stakeholder is affected as follows:

High Blood Pressure Patients: The patients taking the medicine directly benefit from this recall. Pfizer was honest with the patients by informing them about the bad medicine they were taking. They were also courageous by issuing the recall as they did it regardless of the backlash they may receive from their patients. By giving the patients the option to change their medicine, they acted with fairness in mind. It is not fair to force someone to do something they may not want. Since they did not do that, they acted in the fairness of the consumer. Overall, all 4 characteristics of Virtue theory were displayed due to the fact that the company managed to issue the recall without causing much dysfunction. They issued the recall and managed self control by not releasing an excess amount of unneeded details.

Pfizer Shareholders: Pfizer shareholders more than likely will not be directly affected by the recall. Since the company was honest with its customers, they are improving their reputation. With an improved reputation, more people may begin to invest in the company. In turn, the price of the company may increase, directly benefiting the shareholders.

Doctors: The Doctors will directly benefit due to more customers looking to switch their medicine out or even to switch their medicine from the Pfizer company due to the impurities found inside. This will result in more business for the doctors, possibly causing a little stress but also causing an increase in sales from their end.

Manufacturers/Employees:

Action Plan

Nitrosamines found in these blood pressure medications are known carcinogens. Nitrosamines are also found in cured and grilled meats, dairy products, vegetables, and water. It is extremely difficult to completely avoid consuming nitrosamines when they are found everywhere. So, there is no immediate risk in taking these blood pressure medications. That means that using these medications for an extended period of time that high risk of cancer is a concern because of the long-term exposure to nitrosamine. This is not safe for patients who take blood pressure medications, like Accuretic. The company could change the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged, but there is still a possibility that as foods and drugs are processed in the body, nitrosamines can also be formed. The current issue here is that Pfizer should think about switching up their production method and not risk the health and safety of the patients who take these medication.


Authors:
        Kyle Dias
        Safia Muftic
        Maxwell Tavitian

References

“Accuretic (Quinapril Hcl/Hydrochlorothiazide): Uses, Dosage, Side Effects, Interactions, Warning.” RxList, RxList, 1 Sept. 2021, https://www.rxlist.com/accuretic-drug.htm

Center for Drug Evaluation and Research. “Information about Nitrosamine Impurities in Medications.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications

Center for Drug Evaluation and Research. “Pfizer Voluntary Nationwide Recall of Lots of Accuretic (Quinapril Hcl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril Hcl/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content.” U.S. Food and Drug Administration, FDA, 22 Mar. 2022, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretic-quinapril-hclhydrochlorothiazide-quinapril-and.

“Drug Approval Package.” Accuretic (Quinapril HCI/Hydrochlorothiazide) NDA# 20-125, 31 May 2001, https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20125_Accuretic.cfm.

Dunleavy, Kevin. “In a Busy Month, Pfizer Extends Recall of Blood Pressure Meds to the UK.” Fierce Pharma, 29 Mar. 2022, https://www.fiercepharma.com/pharma/pfizer-extends-its-pull-back-blood-pressure-meds-uk-busy-month-recalls.

“FDA Announces Recall of Hypertension Medications Due to Potential Cancer Risk.” Cardiovascular Business, 8 Apr. 2022, https://www.cardiovascularbusiness.com/topics/heart-health/fda-recall-pfizer-hypertension-cancer-risk#:~:text=The%20FDA%20has%20announced%20that,an%20elevated%20risk%20of%20cancer

FDA's role in drug recalls. (n.d.). Retrieved April 15, 2022, from https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls

“History of Pfizer.” Pfizer, https://www.pfizer.com/about/history

  Holcombe, M. (2022, March 24). Blood pressure medication recalled over cancer risk concerns. Retrieved April 12, 2022, from https://www.cnn.com/2022/03/23/health/pfizer-blood-pressure-medication-recall-wellness/index.html

Jewett, Christina. “Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk.” The New York Times, The New York Times, 23 Mar. 2022, https://www.nytimes.com/2022/03/23/health/pfizer-recall-blood-pressure-drug-cancer.html.

Lee, Bruce Y. “Pfizer Recalling 3 Blood Pressure Medication Types Due to Cancer Concerns, FDA Says.” Forbes, Forbes Magazine, 14 Apr. 2022, https://www.forbes.com/sites/brucelee/2022/03/26/pfizer-recalling-3-blood-pressure-medication-types-due-to-cancer-concerns-fda-says/?sh=183003ba5811.

Lou, Nicole. “Another Class of Antihypertensive Recalled.” Medical News, MedpageToday, 25 Mar. 2022, https://www.medpagetoday.com/publichealthpolicy/publichealth/97883.

Newsy. “Pfizer Recalls 3 Blood Pressure Drugs Due to Cancer Risk.” WFTS, WFTS, 23 Mar. 2022, https://www.abcactionnews.com/news/national/pfizer-recalls-3-blood-pressure-drugs-due-to-cancer-risk.

“Nitrosamines.” Nitrosamines - an Overview | ScienceDirect Topics, https://www.sciencedirect.com/topics/neuroscience/nitrosamines

“Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (Quinapril Hcl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril Hcl/Hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content.” Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntary-nationwide-recall-lots-accuretictm

Romo, Vanessa. “Pfizer Launches a Recall of Blood Pressure Drugs Due to a Potential Carcinogen.” NPR, NPR, 22 Mar. 2022, https://www.npr.org/2022/03/22/1088075045/pfizer-blood-pressure-recall-carcinogen

Salazar, Heather. Kantian Business Ethics. N.d.

Salazar, H. The Business Ethics Case Manual. N.d.


Friday, May 6, 2022

Unilever and Johnson & Johnson: Recall Antiperspirant Products After Elevated Levels of Benzene had been Discovered (March 31, 2022)

 Case Controversy

It has been discovered that numerous media organizations have published news and articles in response to various corporations who have released aerosol items that have since been recalled due to the discovery of carcinogens. One company in particular that has experienced their products containing cancer causing chemicals is Unilever. Due to the presence of “benzene”, a cancer causing chemical, in several products, Unilever in March of 2022 had announced to the public that they had to recall everyday consumer products due to carcinogens being found in testing samples.  These products were recalled from the shelves of stores and pulled from online sales due to the concern that benzene, which has been associated with various types of cancer after long-term exposure, was present in a couple of commodities. During an internal investigation, high quantities of benzene were discovered product samples which lead to Unilever having to announce the voluntary recall of two different kinds of Suave 24 hour aerosol antiperspirants. Suave 24 Hour Protection Aerosol Antiperspirant Powder (4 oz. and 6 oz.) and Suave 24 Hour Protection Aerosol Antiperspirant Fresh (6 oz.), with an expiration date through September 2023, were the two commodities that had been affected and contained benzene (Albert, 2022). Unilever spoke out on their recall and stated “while benzene is not an ingredient in any of our products, our review showed that an unexpected level of benzene came from the propellant that sprayed the product out of the can” (FDA, 2021). The company also went on to say that the exposure to the quantity of benzene observed from review, on a daily basis is unlikely to be harmful to one’s health. However Unilever has initiated this recall that is voluntary for the two Suave antiperspirant aerosol products as a result of these findings and out of an excess of caution for the consumer (Torchinsky, 2022). When it comes to the question of how benzene could have exactly gotten into these aerosol products that individuals use on a daily basis, the company went on to say that “investigators believe it may be due to the manufacturing process and cross-contamination” (Yates, 2021). Suave products were only available in limited quantities in retail stores and online stores in the United States and were discontinued in October of 2021. 

Recalled Sauve Products (Image from Unilever Recall Page)

A month after the product was discontinued a class action lawsuit was filed against Unilever following a study made by Valisure. On November 3rd, 2021 Valisure released a petition requesting the Commission of Food and Drugs to request recalls and revise industry guidance. Valisure found that body sprays and found that 54% of the samples tested contained elevated levels of benzene and in some as much as 18 parts per million (ppm) (Valisure). Which is much greater than the FDA’s limit of 2 ppm if  “unavoidable to produce a drug product with a significant therapeutic advance” (FDA Alerts). The Suave Powder Aerosol products in 4 oz. and 6 oz. sizes contained an average of 5.21 ppm and 0.97 ppm respectfully. Suave Fresh contained an average of 2.30 ppm within tested samples. This is a huge concern for customer safety because the Environmental Protection Agency (EPA) has  “estimated that lifetime exposure to benzene at 0.4 parts per billion (‘ppb’), or 0.0004 ppm, will increase the risk of developing cancer in humans” (Valisure). Making these products harmful to consumers uses them everyday. Furthermore, Valisure also stated that if a contaminated product was used in the bathroom (20 sq. ft. with 8 ceilings) the air could contain benzene at 6 ppb. So if someone used a contaminated aerosol product everyday, in an enclosed space, they would dramatically increase their chance of getting cancer. 

Retailers had been informed the recalled products must be removed from their shelves. The company also stated that the customers that had been affected by these purchased products would be reimbursed by Unilever. Recalls regarding the chemical, “benzene”, was not the best news for Unilever nor is it a great look to have cancer associated with their products. On the other hand, this was great news for the general public that regulators were able to quickly discover the problem.

Not only have antiperspirants been recalled in recent months, but Johnson & Johnson (J&J) has also voluntarily recalled four of their sunscreen products. Specifically, Neutrogena® Beach Defense, Neutrogena® Cool Dry Sport, Neutrogena® Invisible Daily™ defense, Neutrogena® Ultra Sheer, and Aveeno® Protect + Refresh. All five of these products are aerosol sunscreen and all of them were found to have benzene contained within the propellant, similar to Unilever’s Sauve products. J&J also advises customers to do the same as Unilever, to stop using the products and dispose of them properly. Any customers with questions are encouraged to call J&J’s Customer Care Center at 1-800-458-1673.



Recalled Neutrogena Products (Image from ksat.com) 


Timeline of Events




Stakeholders

Any sizable business has plenty of stakeholders to help the business strive and grow. The responsibilities of a stakeholder include contribution of not only their money but more importantly time to better the company. In this case we are talking about the stakeholders involved with Neutrogena. Unfortunately over the last few years we have become very familiar with Neutrogena stakeholders. That being Johnson and Johnson(J&J). J&J works side by side with Neutrogena to promote sustainability. Main end goal is to maintain the competitive advantage over other rival companies. The current CEO to date for Neutrogena is Alex Gorsky and CFO Alexander Caruso.  Now the thing with stakeholders is that when the company is thriving they get a good amount of credit, on the contrary when the company is doing poorly they take most of the hit. As one could imagine during this time in which the recalls began a lot of it fell on J&J. Another major stakeholder that was involved are called external stakeholders. This includes doctors and other organizations that promote these Neutrogena products and ensure safe and healthy use. Now imagine how the doctors felt once they discovered that Benzene was in the product. This makes people lose trust in the doctors even though it shouldn't be. The stakeholders allow for the reputation of the product to remain positive and Neutrogena did just that and are still one of the top selling cosmetic companies globally.

Unilever stakeholders are different in comparison to Neutrogena, Unilever prides itself on having a strong relationship with many of its stakeholders ranging from customers to suppliers, shareholders, scientists, as well as trade associations. When conducting research it was difficult to find the exact names of these stakeholders, but  is it important to notice that Unilever makes a point to take into consideration all of them. The current CEO of Unilever is Alan Jope as of 2019 which is fairly recent. As mentioned above, many of the stakeholders' responsibilities are to grow the company as much as possible.  

The General Public is affected because Unilever and J&J  are very large corporations spread across many industries and are owners of same brand products like Ben & Jerry’s and Neutrogena. Due to a lack of quality control/product investigation there could be other products also containing potentially harmful products without anyone knowing. 


Individualism

In this class there were two theories of Individualism: Friedman's Individualism and Machan’s Individualism. Friedman’s Individualism states “The only goal of business is to profit, so the only obligation that the business person has is to maximize profit for the owner or stockholders within the law of the land” (Salazar). This theory does not take into the consideration the identity of the company and the motivations of investors and customers to choose socially responsible businesses. However, Machan’s Individualism does take this into account, stating that the primary goal of the business is to profit, with the law, BUT may have goals not aimed at profits (such as being a socially responsible business).

In the case of Unilever, under both Friedman’s and Machan’s Individualism Unilever used unethical business practices to gain profits because they were above the legal limit of benzene in their products. A class action lawsuit was filed, against Unilever, on November 12th, 2021 claiming that “as much as 5.51 parts per million (ppm) of benzene” (Shaak) were found in Unilever products. This is above the FDA’s limit of 2 ppm if the presence of benzene is “unavoidable” during the manufacturing of a product. The actions of Unilever are impermissible under an individualist point of view because they did not follow the rules & recommendations set forth by the FDA. While the lawsuit states that not all of the tested samples contained benzene, this shows that the presence of benzene is not “unavoidable” because some products were able to be produced without containing benzene. 

Let's say for example Unilever was below the FDA’s regulation 2 ppm in their product. It highlights one of the shortcomings of Freidman’s Individualism because investors are supporting a non-socially responsible business. An individualist would view Unilever’s actions as ethical because they are profiting within the law. However, Unilever did do the socially responsible thing by voluntarily recalling their product but this did occur 4 months after the lawsuit was filed. Back to the case at hand,  Unilever’s business practices were not ethical because they did not profit within the law.


Utilitarianism

Ethical theory played an important role in this decision, because the companies could have attempted to hide these findings in order to uphold the companies name and overall stature. As soon as the lab results came back immediate action was taken in order to protect the health and safety of its consumers. The two Suave antiperspirant arousal sprays were immediately recalled to protect the lives of the consumers. This case stated above can be linked to the ethical theory of utilitarianism. Utilitarianism states that all parties are treated honestly and with the utmost respect, as well as promotes happiness among the greatest number of people. “Utilitarianism is one of the most powerful and persuasive approaches to normative ethics in the history of philosophy”(Stanford). A Utilitarian wants everyone's happiness to count as the same, in other words maximizing the good. After conducting a sufficient amount of research one can conclude that even though the Unilever situation was extremely severe the company did everything to make sure that it had full transparency and despite  being in the wrong. When Unilever realized their mistake there made sure that the appropriate actions were taken in the benefit of all who were affected. Their biggest concern was the consumer, further explaining how the ethical theory of utilitarianism can be closely connected to this case. The company took the necessary precautions for the good of the people. The only aspect that wasn't fully explained was how the products get contaminated in the first place. Now the company could be hiding the aspect, however if what they say is true they might not have an actual answer.  


Kantianism

Unilever voluntarily recalled their two Suave antiperspirant aerosol products due to the potential of cancer-causing chemicals. From a Kantian perspective, this was the most ethically desirable approach to handle the situation for almost everyone involved. Like Kantian ethics in general, the Kantian understanding of business ethics encourages acting with respect toward all human individuals. Rational decisions must be ethical, according to Kantian business ethics theory. Being ethical refers to the rules or standards that govern proper behavior or performance. The decision you make should be driven by obligation rather than self-interest. Good will is at the heart of Kantian ethics. According to Kantian Business Ethics, the definition of good will is: “rationally which chooses to do what is right for the reason it is good” (Salazar). We, as individuals, all have value derived from our moral and cognitive abilities, and therefore we should all act in ways that demonstrate our gratitude for that value. When you’re in control of a company that services millions of human individuals, you should constantly be faithful and trustworthy to the customers who support you while also helping them. A company should not be exempt from ethical principles in general. Kantianism's four essential principles are to act logically, to assist others in making rational decisions, to respect individuals, and to be motivated by Good Will, looking to do the right thing because it is the correct thing to do. In this case, Unilever responded in accordance with its duty to protect its customers’ well-being by issuing a statement warning its customers who had purchased the product that benzene, a cancer causing chemical, had been discovered in the aerosol cans. Despite the fact that the amount of benzene identified on a daily basis is unlikely to be hazardous to one's health, they made certain to inform clients, be honest, and demonstrate that they care about their error. Unilever has ensured that the health and safety of individuals were prioritized, as well as the well-being of customers. 

The Categorical Imperative which is the Law of Rationality, is a test that determines whether a behavior is acceptable or unacceptable, is part of this theory. The Formula of Humanity, which asserts that using people as a method to get what you want is immoral because it exploits them, is one of the most important formulations of the categorical imperative. (Salazar) According to this ethical theory, Unilever passed the Categorical Imperative since they voluntarily recalled Suave aerosol cans for the health and safety of its customers, not for the sake for the company to make more money when they knew that quantity of benzene on a daily basis is unlikely to be harmful to one’s health. Unilever does not gain anything by recalling the product, if anything they are the ones that are losing and are the ones that actually care about their customers' health currently and down the line. After Analyzing from Kant's ethical theory, it is clear that Unilever actions were acceptable and that they had followed all four essential principles. Remember life is precious and we must protect it. 

Virtue Theory

Back in the 4th century B.C., Aristotle developed the virtue theory which consists of four main characteristics. These include courage, temperance/self-control, honesty, as well as justice/fairness. For starters, the virtue theory was established to help those differentiate between what’s good, and what isn’t good. Understanding that seeking a purpose and only doing what best to achieve that said purpose, results in virtue. The courageous characteristic takes a part in this case, representing the risk-taking and willingness to take a stand for the right ideas and actions (Salazar, 7). After the review of both Suave products, the recall notice explained that the benzene levels came from the propellant that sprays the product. Immediately, Unilever acted and issued a nationwide recall. Research concluded that the levels of benzene found were slightly elevated and only capable of causing little to no harm. 

However, the company chose to make the ethical decision, and take the product off the market anyways, even though there is a high percent chance that the benzene may have never been noticed, and or cause any problems. Moving on to temperance which is defined as “reasonable expectations and desires” (Soloman, 34), the case ties into this characteristic considering Unilever uses this knowledge to grant their customers with trustworthy products. People have faith in the companies they are giving their money too and expect nothing less than reasonable products that contribute to their purpose. Unilever ethically recalled their products considering it was unsafe, and only wishing to purchase safe products, is a reasonable customer request. Not to mention, Unilever also ethically chose to take the honest route and alert the FDA on its benzene findings as soon as it was discovered, remaining in agreement with their customers. Lastly, Unilever maintains justice to its company overall, remaining true to their business model that I previously mentioned above. Recalling their products was the ethical move considering they are still known for their high-quality products and maintaining their consumer’s trust.


Action Plan

There have been many companies in past months recalling their products because they contain human carcinogens. Two of Unilever’s Suave antiperspirant products contained elevated levels of benzene and J&J’s Neutrogena products also contained benzene. This is a problem because carcinogens are materials or substances that can cause cancer, which can lead to potential deadly health conditions. For example, from prolonged exposure to benzene it can cause the blood cancer Leukemia. Leukemia which can lead to weakened immune systems and weight loss. This is especially a problem when consumers do not know that the products contain human carcinogens. Since benzene was only found in the propellant that sprays the antiperspirant, in the Suave products, it should be very easy for Suave to remove the benzene from their products.

A new mission statement for Unilever and J&J would be very helpful in helping them recover from these controversies’. For instance, the new mission statement might be “We are dedicated to the health and safety of our customers and promise to produce safer quality products.” To go along with the mission statement these companies should also follow some core values going forward. Some values may be customer health, quality consistency, customer services, and trust. The companies will meet these values when releasing products that have no carcinogens within them (that have also been tested for common carcinogens and other harmful substances). Also, they publish documentation that there are no harmful substances in all of their products and even add a URL to the documentation on the product. This will build trust because customers will know exactly what they are buying. One step these companies can take to ensure they practice ethical business in the future is to have informative courses on Good Manufacturing Practice (GMP). GMP are regulations promoted by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (ISPE). By having management and executives take this informative course it will ensure that Unilever and J&J have consistent quality products being produced. The last part of the plan could be to send out coupons, with the documentation, to customers to encourage them to buy new products. This plan will promote business profits and productivity because customers will know that the product they are purchasing is safe, healthy, and free of harmful substances and therefore be more inclined to purchase the products. Also, by including documentation of safety and quality of the product it will show that Unilever and J&J are trustworthy and are dedicated to being an ethical business.  


References

Albert, Victoria. “Two Types of Suave Aerosol Deodorant Recalled Due to Elevated Benzene Levels.” CBS News, CBS Interactive, 2 Apr. 2022, www.cbsnews.com/news/suave-recall-deodorant-two-types-aerosol-recalled-benzene/. 

FDA. “FDA Alerts Drug Manufacturers to the Risk of Benzene Contamination.” U.S. Food and Drug Administration, FDA, 23 Dec. 2021, https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs. 

FDA. “Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene.” U.S. Food and Drug Administration, FDA, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unilever-issues-voluntary-nationwide-recall-suave-24-hour-protection-aerosol-antiperspirant-powder#recall-announcement.

ISPE. “Good Manufacturing Practice (GMP) Resources.” ISPE, 23 Jan. 2019, https://ispe.org/initiatives/regulatory-resources/gmp. 

Salazar, Heather. “Does Business Ethics Make Economic Sense? .” Economics and Individualism Online Lecture, 5 May 2022, Springfield, Massachusetts. 

Shaak, Erin. “Class Action Alleges Carcinogen Benzene Detected in Certain Suave Antiperspirant Products.” ClassAction.org, Newswire, 16 Nov. 2021, https://www.classaction.org/news/class-action-alleges-carcinogen-benzene-detected-in-certain-suave-antiperspirant-products. 

Torchinsky, Rina. “Suave Antiperspirants Are Recalled Because Benzene Was Found in Some Samples.” NPR, NPR, 1 Apr. 2022, www.npr.org/2022/04/01/1090343033/suave-antiperspirants-are-recalled-because-benzene-was-found-in-some-samples.

Valisure, “Valisure Citizen Petition on Benzene in Body Spray Products” 3 Nov. 2021

Yates, Jacqueline Lauren. ABC News, ABC News Network, 21 Dec. 2021, abcnews.go.com/GMA/Style/pg-recalls-products-pantene-herbal-essences
                spice/story?id=81863689.