Class II
Terminated
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
This recall has been terminated (originally issued October 16, 2019).
- Recall Initiated
- September 23, 2019
- Posted
- October 16, 2019
- Recall Number
- D-0130-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 196,408 bottles
- Firm Location
- Morton Grove, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Distribution
Nationwide USA and Puerto Rico
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
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