Recalls / Class II
Class IID-1042-2018
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 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 US1259
Why it was recalled
Defective Container: Tamper Evident foil seal not completely intact.
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
- 38,280 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2018-07-24
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2022-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1042-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.