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Recall Observatory FDA recall evidence

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

September 23, 2019

Class II

Product summary

Firm
Morton Grove Pharmaceuticals, Inc.
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications