FDA-Drug2012-07-25Class III
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.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Hazard
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Sold states
Nationwide
Affected count
73,746 bottles
Manufactured in
120 Vintage Dr NE, Huntsville, AL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1417-2012Don't want to check this manually?
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