Rewrite: Broadened Over-The-Counter Drug Recall
Key Takeaways:
- A broader recall of select over-the-counter drugs has been implemented by a subsidiary of Johnson & Johnson. This includes around 500 product batches, now affecting Motrin, Benadryl, Rolaids, St. Joseph aspirin, and various forms of Tylenol.
- The recall was a result of around 70 consumers reporting illnesses attributed to these products, with symptoms ranging from minor stomach pains and nausea to more severe ones like vomiting and diarrhoea. The illnesses are linked to a mouldy smell from the drugs.
- This smell is suspected to come from a chemical, 2,4,6-tribromoanisole (TBA), used to treat wooden pallets where the product packaging materials are stored. TBA is known for giving a mouldy taste to wine and it’s suspected that it seeped into the packaging material and consequently, the products.
- The U.S. Food and Drug Administration has criticized the sluggishness in reporting and investigating this issue by the company, highlighting the corporate responsibility of drug manufacturers to be proactive and thorough.
- In response, McNeil Consumer Healthcare has halted shipment of products made using materials shipped on these pallets and has instructed its suppliers to stop using the pallets. They have also assured oversight of the situation in consultation with the FDA.
In what may come as a shock to many, a subsidiary of Johnson & Johnson has expanded upon their previous recall of select over-the-counter drugs. This move was necessitated after record incidences of customers falling ill due to a mouldy smell emanating from the medications.
Rapid Implementation of Recall Measures
This decision to widen the recall followed Deborah M. Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration’s press conference early in the morning one day.
“In response to the situation, McNeil Consumer Healthcare has decided to extend its voluntary over-the-counter drug recall to include about 500 product batches,” declared Autor. The recalled drugs now include specific lots of Motrin, Benadryl, Rolaids and St. Joseph aspirin in addition to the previously announced Tylenol.
Reports of Illness
Files of about 70 consumers have been documented, reporting illnesses attributed to these products. Symptoms range from minor disturbances like stomach pains and nausea to more severe ones like vomiting and diarrhoea.
The company chalks up the contamination to a chemical used to treat the wooden pallets where the packaging material is stored and transported. The chemical in question, 2,4,6-tribromoanisole (TBA), also naturally occurs and is known for giving a mouldy taste to wine.
Lack of In-depth Research
As Autor mentioned, “The consequences of exposure to this chemical have not been extensively studied. However, serious adverse events have not been reported in medical literature.”
It is suspected that TBA seeped into the packaging material and consequently, the products.
Late Reporting and Investigative Measures
Autor, although praising the company for extending its recall, criticized it for its sluggishness in reporting and investigating the issue. She stressed on the corporate responsibility of drug manufacturers, stating, “When a problem surfaces with their products, they must be proactive, quick and thorough to assure the quality, safety and effectiveness of their output, and to protect consumers.”
The agency has since issued warnings to McNeil about the issues and urged them to recall affected products.
Actions Taken by the Manufacturer
McNeil, on its part, has released a statement saying that it has halted the shipment of products made using materials shipped on these wooden pallets and has instructed the suppliers to stop using these pallets. Furthermore, the company has assured that they will keep a close eye on the situation and will continue to consult with the FDA.
Products Included in the Recall
The recall encompasses specified lots of:
– Regular Strength Tylenol
– Extra Strength Tylenol
– Children’s Tylenol
– Tylenol 8-Hour
– Tylenol Arthritis
– Tylenol PM
– Tylenol Simply Sleep
– Children’s Motrin
– Motrin IB
– Benadryl
– Rolaids
– St. Joseph aspirin
To learn more about the recall, visit the McNeil Consumer Healthcare page.
