Morton Grove Pharmaceuticals, Inc. recalls Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuti…
- Recall date
- February 21, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0713-2022
- FDA classification
- Class II
- Brand / firm
- Morton Grove Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide USA and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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