US Drug Recall Register
Class I · High risk Terminated Initiated Dec 6, 2012 (14 years ago)

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a)…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

What was recalled

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.

Recalling firm
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
NDC code
0603-3888-16
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-138-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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