Watson Pharmaceuticals Inc. (WPI) announced that Watson Laboratories Inc. issued a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg.
The company said it received a customer complaint for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen.
Unintentional ingestion of excessive amounts of acetaminophen may potentially result in an adverse event, including 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.
No reports of injuries related to the recalled product have been received to date, the company said.
The recall includes Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, 500 count NDC 00591-0540-05, Lot Numbers 519406A and 521759A both with the expiry date April 2014.
Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
The company said that the affected lots were distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide. The lot numbers can be found on the manufacturer's bottle label. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 0.6 inches in length, blue, bisected capsule shaped, with "Watson 540" de-bossed on one side of the tablet.
The company advised that consumers who have lots 519406A or 521759A should contact their pharmacy or health care professional. Consumers who are unsure if they have the affected lot numbers should consult their pharmacy or health care professional.
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