Morton Grove Pharmaceuticals, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured B…
- Recall date
- September 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0130-2020
- FDA classification
- Class II
- Brand / firm
- Morton Grove Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide USA and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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