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
Reported: December 30, 2020 Initiated: December 9, 2020 #D-0174-2021
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Details
- Recalling Firm
- Morton Grove Pharmaceuticals, Inc.
- Units Affected
- 127,392 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Morton Grove, IL
Frequently Asked Questions
What product 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. Recalled by Morton Grove Pharmaceuticals, Inc.. Units affected: 127,392 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 30, 2020. Severity: Moderate. Recall number: D-0174-2021.
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