FDAFDA · Food and drugs·Recall number D-057-2013
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
Published November 28, 2012 · Recall initiated: September 10, 2012
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Distributor
- Nationwide.
- Lot
- Lot number: C1440512A, Exp 12/13
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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