Recalls / Class II
Class IID-0130-2020
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
- Affected lot / code info
- Lot #: US1450, Exp 10/31/19; US1570, Exp 12/31/19; UT1018, Exp 1/31/19; UT1173, Exp 6/30/20; UT1348, UT1354, Exp 8/31/20
Why it was recalled
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
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
- 196,408 bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2019-09-23
- FDA classified
- 2019-10-08
- Posted by FDA
- 2019-10-16
- Terminated
- 2022-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0130-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.