Recalls / Class II
Class IID-0174-2021
Product
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
- Affected lot / code info
- Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
Why it was recalled
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Recalling firm
- Firm
- Morton Grove Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6451 Main St, N/A, Morton Grove, Illinois 60053-2633
Distribution
- Quantity
- 127,392 bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2020-12-09
- FDA classified
- 2020-12-23
- Posted by FDA
- 2020-12-30
- Terminated
- 2022-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0174-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.