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Vintage Pharmaceuticals LLC DBA Qualitest Pharmace Recall: HYDROXYZINE HYDROCHLORIDE ORAL

Vintage Pharmaceuticals LLC DBA Qualitest Pharmace Recall: HYDROXYZINE HYDROCHLORIDE ORAL is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals; Product: HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle

Recalling firmVintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
ProductHYDROXYZINE 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 recallImpurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionNationwide
Recall initiated20120706
Recall numberD-1417-2012
Categorydrug
StateAL
CountryUnited States

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