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The quality of over-the-counter diarrhea and heartburn medicines such as Imodium, Mylanta and Pepcid may be compromised, according to a report released by the Food and Drug Administration (FDA). The preliminary report is based on a series of FDA investigations into Johnson & Johnson’s Lancaster, N.J., factory, which found a pattern of “ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping,” according to the Associated Press. In some cases, the report states, batches of medicine made during equipment failures were not checked for quality.
J&J is still trying to recover from eight recalls since September involving tens of millions of bottles of over-the-counter medicines for both adults and children. Those recalls included Tylenol, Motrin, Benadryl and Zyrtec, and were initiated based on consumer reports of unusual odors in the adult medicines that in some cases was associated with non-serious gastrointestinal events, and reports of foreign material floating in the children’s medicines.
The new report is based on inspections performed at J&J’s Lancaster, N.J., plant on 12 consecutive business days from June 22 through July 9. Twelve separate violations were listed in the preliminary report. The FDA says it has not determined its next action at this time, but is working on finalizing the report.
The Lancaster plant is a joint venture between J&J and Merck Consumer Pharmaceuticals Co. The companies say they are taking the issues seriously and plan to fully address the agency’s concerns as quickly as possible.


