FDAFDA · Food and drugs·Recall number D-0713-2022
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.
Published March 9, 2022 · Recall initiated: February 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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