D-1417-2012 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2012
- Initiation Date
- July 6, 2012
- Termination Date
- December 9, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,746 bottles
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.
Distribution Pattern
Nationwide
Code Information
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