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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

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.
Recall Number D-1417-2012
Classification Class III
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
Product Distributed Qty 73,746 bottles
Reason For Recall Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Event Detail

Event Id 62495
Product Type Drugs
Status Ongoing
Recalling Firm Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
City Huntsville
State AL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide