FDA-Drug2019-10-16Class II

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

Morton Grove Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide USA and Puerto Rico
Affected count
196,408 bottles
Manufactured in
6451 Main St, N/A, Morton Grove, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0130-2020

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