FDAFDA · Food and drugs·Recall number D-0174-2021
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
Published December 30, 2020 · Recall initiated: December 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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