drugs Class III Updated 2012-07-25

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1

Recalled Product

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.

Hazard / Issue

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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