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.
Reported: July 25, 2012 Initiated: July 6, 2012 #D-1417-2012
Product Description
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.
Reason for Recall
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Details
- Recalling Firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Units Affected
- 73,746 bottles
- Distribution
- Nationwide
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals. Units affected: 73,746 bottles.
Why was this product recalled? ▼
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2012. Severity: Low. Recall number: D-1417-2012.
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