The FDA Enforcement Report released yesterday included one recall affecting more than 70 over-the-counter drugs—78, I think, but I started to feel dizzy after 71. The recall included some extremely common drugs such as ibuprofen and naproxen. (The list is too long to reproduce, so I’ve attached a link to the FDA Enforcement Report.
The drugs were recalled due to the possibility of, using the FDA’s language, “multiple product packaging mix-ups,” or in other words, “we have no idea what’s in that package.” But don’t worry, it only affects more than 500 million packages distributed nationwide. Oh, and the recall was initiated on February 14 and it was in the FDA Enforcement Report yesterday, about 3½ months later.
Taken any ibuprofen or naproxen recently? Are you sure?
RECALLING FIRM/MANUFACTURER
Heartland Repack Services, LLC, Toledo, OH, by telephone between February 14, 2007 and February 20, 2007. Firm initiated recall is ongoing.
REASON
Misbranding. There is the possibility of multiple product packaging mix-ups. An OTC drug, Rx drug ,or nutritional supplement other than what is indicated on the product labeling, may be inside the packaging.
VOLUME OF PRODUCT IN COMMERCE
566,734,636 units
DISTRIBUTION
Nationwide
Link to FDA Enforcement Report with full list and lot codes:
http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01006.html