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
Reported: October 16, 2019 Initiated: September 23, 2019 #D-0130-2020
Product Description
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
Details
- Recalling Firm
- Morton Grove Pharmaceuticals, Inc.
- Units Affected
- 196,408 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Morton Grove, IL
Frequently Asked Questions
What product 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. Recalled by Morton Grove Pharmaceuticals, Inc.. Units affected: 196,408 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 16, 2019. Severity: Moderate. Recall number: D-0130-2020.
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