Class II
Terminated
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.
This recall has been terminated (originally issued March 9, 2022).
- Recall Initiated
- February 21, 2022
- Posted
- March 9, 2022
- Recall Number
- D-0713-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Morton Grove, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
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