Mylan Inc. has issued a recall of three lots of the painkiller tablets, hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, due to the potential risk that these lots (lots 3037841, 3040859 and 3042573) may exceed the potency stated on the label. The hydrocodone bitartrate and acetaminophen tablets were manufactured by Qualitest Pharmaceuticals, a subsidiary of Endo Health Solutions. Mylan repackaged and distributed the product under the UDL Laboratories Inc. label.
On Dec. 6, 2012, Qualitest voluntarily recalled 101 lots of hydrocodone bitartrate and acetaminophen tablets, stating in its press release, that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen. The affected lots, were distributed between Feb. 20 and Nov. 19 this year to wholesale distributors and retail pharmacies in the United States.
Hydrocodone bitartrate and acetaminophen are indicated for the treatment of moderate to moderately-severe pain. The increased content of hydrocodone could result in more severe or frequent side effects, such as sedation or respiratory depression, especially in elderly patients who have severe kidney or liver impairment, or patients taking interacting medications, e.g., other sedating medication or certain antidepressants. Unintentional administration of a higher dosage of acetaminophen could cause liver damage, particularly in patients on other acetaminophen-containing medications, patients with liver dysfunction, and people who consume more than three alcoholic beverages a day.
The FDA is aware of this recall and additional information can be found on its website.