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Recall Observatory FDA recall evidence

Drug product

Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.

D-0558-2022

February 09, 2022

Class II

Product summary

Firm
Lannett Company, Inc.
Event
Event 89551
Status
Terminated
Classification
Class II
Quantity
23,598 bottles
Official record key
drug-enforcement:D-0558-2022

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Code information: Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023

Distribution pattern: Product was distributed nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification