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
Reported: November 28, 2012 Initiated: September 10, 2012 #D-057-2013
Product Description
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
Reason for Recall
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Details
- Recalling Firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Units Affected
- 14,445 bottles
- Distribution
- Nationwide.
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals. Units affected: 14,445 bottles.
Why was this product recalled? ▼
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 28, 2012. Severity: Critical. Recall number: D-057-2013.
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