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Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets
Date:12/6/2012

pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.It is very important that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than 6 tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.

Taking a higher dose of hydrocodone than intended could result in 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 injuries have been reported to date.

Consumers who have the affected lots should contact Qualitest at 1-800-444-4011.  Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional. 

Pharmacists and wholesalers are asked to check their inventories for the affected lots, segregate any material from the lots, and to contact MedTurn at 1-800-967-5952 for instructions on product return.  Pharmacies that received the affected lots will receive a copy of this press release with their recall notification information to be prominently posted 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
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SOURCE Qualitest
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