FDAFDA · Food and drugs·Recall number D-1417-2012
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
Published July 25, 2012 · Recall initiated: July 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Distributor
- Nationwide
- Lot
- Lot #s: L030F11A, L054F11A, Exp 05/13; L095E10A, Exp 06/13; L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13; L094L10A, Exp 12/13; and L100L10B, Exp 01/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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