Drug 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
D-0130-2020
Product summary
- Event
- Event 83858
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196,408 bottles
- Official record key
drug-enforcement:D-0130-2020
Official wording
Reason: Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Code information: 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
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications