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 60053, NDC 60432-466-08.
Reported: March 9, 2022 Initiated: February 21, 2022 #D-0713-2022
Product Description
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 60053, NDC 60432-466-08.
Reason for Recall
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Details
- Recalling Firm
- Morton Grove Pharmaceuticals, Inc.
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Morton Grove, IL
Frequently Asked Questions
What product was recalled? ▼
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 60053, NDC 60432-466-08.. Recalled by Morton Grove Pharmaceuticals, Inc..
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 9, 2022. Severity: Moderate. Recall number: D-0713-2022.
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