Product Safety Recalls

Product Safety Recalls

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Recall D-0171-2024

Page Last Updated: January 9, 2024

Description: Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Recall D-0171-2024 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberD-0171-2024
Event ID89450
DistributionNationwide USA
Quantity1 unit
Recall ReasonCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Drug ClassificationClass II
Drug Code Info20240103
Recall Initiation Date20220126
Report Date20240103
Classification Date20231226
Address7200 Cardinal Pl W
Dublin, OH 43017-1094
United States
Recalling FirmCARDINAL HEALTHCARE
Initial Notification Letter
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