Hydrocodone bitartrate and acetaminophen lots recalled for potential for oversized, superpotent tablets

September 25, 2012
From staff reports
From staff reports

Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

A customer complaint was received 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. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Unintentional ingestion of excessive amounts of hydrocodone may result in an adverse event, including an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants. No reports of injuries related to the recalled product have been received to date.

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 expiration date April 2014.

The affected lots were distributed between June 27, 2012 and July 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 1 side of the tablet.

Consumers who have lots 519406A or 521759A should contact their pharmacy or healthcare professional. Consumers who are unsure if they have the affected lot numbers should consult their pharmacy or healthcare professional.

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 (855) 393-5728 for instructions on product return. Pharmacies that received lots 519406A or 521759A will receive a copy of a Watson