Qualitest Issues Voluntary, Nationwide Recall For One Lot Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 Mg/500 Mg Due To The Potential For Oversized Tablets

Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, segregate any material from the lot, and to contact MedTurn at 1-800-967-5952 for instructions on product return.  Pharmacies that received lot C1440512A will receive a copy of this press release with their recall notification information. In order to make your patients aware of this recall, please post the enclosed press release prominently in the pharmacy area.

For more information please contact Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.  Reports of adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.

• Online: www.fda.gov/medwatch/report.htm  
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Health Solutions (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics ( www.endo.com). 

SOURCE Qualitest

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