FDA-Drug2020-12-30Class II
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Morton Grove Pharmaceuticals, Inc.
Hazard
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Sold states
Nationwide USA and Puerto Rico
Affected count
127,392 bottles
Manufactured in
6451 Main St, N/A, Morton Grove, IL, United States
Products
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2021Don't want to check this manually?
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