News|Articles|April 21, 2005

Drug Recalls

Drug Recall

The US Food and Drug Administration has logged three drugrecalls, all inititated by the manufacturers, since March 11. Thethree recalls are:

  • On March 15, McKesson Packaging Services (Concord, NC), startedsending out letters recalling  4755 boxes of institutional-useSky brand blister packs and punch cards of acetaminophen (manufacturedby Magno-Humphries Laboratories of Tigard, OR) that might contain metalparticles.

  • On March 11, Malinckrodt (Berkeley, MO) began its recall of1194 thousand-tablet bottles of propoxyphene napsylate andacetaminophen tablets because the bottle label referred to pinktablets, while those batches of the product were white.

  • On April 4, Wyeth's Richmond Division (Richmond, VA) becanrecalling 28,727 thousand-tablet bottles of Premarin conjugatedestrogen tablets (in 0.625 and 0.3 mg dosages), citing dissolution failures.

–Douglas McCormick


Related to this article

Ask the Expert: Post-Approval Changes
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.