Prednisolone Sodium Phosphate Oral Solution recall: Impurity Out of Spec
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
Why was Prednisolone Sodium Phosphate Oral Solution recalled?
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Quantity
- 196,408 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)