Recalls / Class I
Class ID-057-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
- Affected lot / code info
- Lot number: C1440512A, Exp 12/13
Why it was recalled
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Recalling firm
- Firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 14,445 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-09-10
- FDA classified
- 2012-11-16
- Posted by FDA
- 2012-11-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-057-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.