FDAFDA · Food and drugs·Recall number D-0130-2020
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
Published October 16, 2019 · Recall initiated: September 23, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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