Records audit prompts Tylenol, Rolaids recalls

It's death by a thousand cuts: Another Tylenol recall follows continued digging by McNeil into records documenting production prior to last April's manufacturing suspension at its Fort Washington, PA, plant. The current recall, made on Friday, includes select lots of Tylenol products (8 Hour, Arthritis Pain and treatments for upper respiratory conditions), as well as lots of Benadryl, Sudafed and Sinutab.

McNeil says in an announcement that the recall is precautionary. Production records identified cases of improper equipment cleaning or inadequate documentation. "It is very unlikely that this impacted the quality of these products," says the announcement.

The wholesale-level callback, which affects the U.S., the Caribbean and Brazil, marks the first Tylenol recall of 2011. Additional recalls may follow as J&J continues its audit of Fort Washington production records.

Simultaneously, the J&J unit is recalling Rolaids Multi-Symptom Berry Tablets. Labeling excluded the "Does not meet USP" statement as required.

Notwithstanding CEO Bill Weldon's statements to the contrary, even the daily press is now including the phrase "systemic breakdown" in its coverage of the J&J recalls saga. According to the New York Times, "the number and variety of problems have stirred concern among government officials and consumers that the McNeil unit has suffered from a systemic breakdown of its manufacturing procedures."

- see the recall notice
- here's the NYT article


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.