Morton Grove Pharmaceuticals, Inc. recalls Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150…
- Recall date
- December 9, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0174-2021
- FDA classification
- Class II
- Brand / firm
- Morton Grove Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide USA and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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