Labeling and packaging issues are behind two Endo Pharmaceuticals product recalls last Friday. Endocet (oxycodone/acetaminophen) tablets, 10 mg/325 mg, in 100-count bottles, were found to contain some pills having a 650-mg dosage of acetaminophen. The higher-dose pills were identified by their larger size and different shape and markings, according to a company announcement.
On the same day, Endo unit Qualitest made a retail-level recall of Butalbital, Acetaminophen, and Caffeine tablets (50 mg/325 mg/40 mg), and Hydrocodone Bitartrate and Acetaminophen Tablets (7.5 mg/500 mg). In this case, one 500-count bottle of Butalbital, Acetaminophen, Caffeine was incorrectly labeled Hydrocodone Bitartrate and Acetaminophen. The 1,000-count bottle label carried Lot Number C0590909B. Lots C0390909A, C0400909A and C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.
These Endo lots were distributed between April 19 and May 10, 2011 to wholesalers in several U.S. states. The Qualitest products went to wholesalers and retailer between November 13, 2009 and April 9, 2010.
As reported last month, labeling errors come in two varieties: wrong-label/bottle and label-content errors. Endo appears to have suffered both.
- here's the Endo release
- see the Qualitest announcement