Table of Contents
PARSIPPANY, N.J. — Watson Laboratories Inc. has issued a voluntary, nationwide recall for two lots of hydrocodone bitartrate and APAP tablets 10 mg/500 mg.
The company said late Friday that a customer complaint was received for tablets that were thicker and darker shade than the other tablets, and it’s possible that some tablets from the affected lots exceed the weight specification and may contain higher than indicated amounts of the hydrocodone bitartrate and/or acetaminophen.
No reports of injuries related to the recalled product have been received to date, according to Watson. Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
The recall includes the following product lots: hydrocodone bitartrate and acetaminophen tablets USP 10 mg/500 mg, 500-count NDC 00591-0540-05, Lot Numbers 519406A and 521759A, both with the expiration date April 2014.
The affected lots were distributed between June 27 and July 18, 2012, to wholesale distributors and retail pharmacies nationwide. The lot numbers can be found on the manufacturer’s bottle label. The tablets are about 0.6 inches in length, blue, bisected capsule-shaped, with "Watson 540" de-bossed on one side of the tablet.
Pharmacists and wholesalers are asked to check their inventories for lots 519406A or 521759A, segregate any material from the lots, and to contact GENCO Pharmaceutical Services at 1-855-393-5728 for instructions on product return.
Watson added that the voluntary recall is being made with the knowledge of the Food and Drug Administration.
