Dexamethasone Elixir recall: Impurity Out of Spec
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL…
Why was Dexamethasone Elixir recalled?
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
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 #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
- Product
- Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL…
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- March 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)