• University of Phoenix
    As the leading online school in the nation, Phoneix University offers various pharmacology online courses to take in your own time.
  • KAPLAN University
    One of the largest online universities with a widely recognized name, Kaplan University offers a myriad of online pharmacology courses that fit your schedule.
Johnson & Johnson; Why Did Johnson Expand a Tylenol Recall in 2009?
by admin on: March 2nd, 2011

On Friday, January 15th, Johnson & Johnson expanded their recent recall (Tylenol Arthritis Caplets dues to smell which resulted in nausea, stomach pain, vomiting, and diarrhea) of Tylenol products to include some batches of Children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, St. Joseph’s Aspirin, Extra-Strength Tylenol, Children’s Tylenol, Eight-Hour Tylenol, Tylenol Arthritis, and Tylenol PM. These drugs, both in caplet form and gel tabs, were recalled in the Americas, the United Arab Emirates, and Fiji. Overall, the FDA reports approximately 70 people either noticed or were sickened by the odor.

Based on internal investigations performed by McNeil Consumer Healthcare (a pharmaceutical subsidiary of J&J), the uncharacteristic smell resulted from the presences of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). While the health effects of TBA have not been well studied, the origin of this contamination has been traced to a J&J facility in Las Piedras, Puerto Rico.

However, the Food and Drug Administration (FDA) believes that McNeil was aware of this problem in early 2008, and did little to investigate the problem. The FDA has since issued a warning letter to McNeil (FDA website; Warning Letter SJN-2010-01) stating that McNeil: (1) failed to thoroughly investigate any unexplained discrepancy, or failure of a batch to meet its specifications whether or not the batch has been distributed, (2) failure of their Quality Control Unit to ensure a thorough investigation was conducted in accordance with accepted policies, and (3) failure to submit required NDA Field Reports (FARs) within three working days of receipt of information concerning change, contamination, or deterioration of their product(s).

Johnson & Johnson had 15 days to respond to this letter where J&J must cite the specific steps taken to correct these violations, and include how each step taken will prevent recurrence of violations. This case has affected pharmacology, increasing the effect of regulations, and raising awareness.

Tags: ,

Leave a Reply