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Recall Observatory FDA recall evidence

Drug 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 60053, NDC 60432-466-08.

D-0713-2022

February 21, 2022

Class II

Product summary

Firm
Morton Grove Pharmaceuticals, Inc.
Event
Event 89624
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0713-2022

Official wording

Reason: Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Code information: Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications