Class II
Terminated
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
This recall has been terminated (originally issued December 30, 2020).
- Recall Initiated
- December 9, 2020
- Posted
- December 30, 2020
- Recall Number
- D-0174-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 127,392 bottles
- Firm Location
- Morton Grove, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
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