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

FDA recall notice · announced October 16, 2019 · Morton Grove Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/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
Quantity: 196,408 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.