Mylan (MYL) Announces Recall of Hydrocodone Bitartrate and Acetaminophen Tabs
Tweet
Share
E-mailGet Alerts MYL Hot Sheet
Join SI Premium – FREE
Mylan, Inc. (NASDAQ: MYL) announced that its Mylan Institutional business is conducting a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573).
The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a Mylan Institutional Inc.) label. Qualitest Pharmaceuticals first initiated the recall on Dec. 6, 2012, due to the possibility 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. As indicated in Qualitest Pharmaceuticals' announcement, unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.
The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a Mylan Institutional Inc.) label. Qualitest Pharmaceuticals first initiated the recall on Dec. 6, 2012, due to the possibility 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. As indicated in Qualitest Pharmaceuticals' announcement, unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
- Kimbell Royalty closes $221.2M mineral rights acquisition
- Hinge Health signs $86M office lease in San Francisco
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
