FDA Drug Class II — Moderate

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

Hazard

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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Products

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 0
Brand
CARDINAL HEALTHCARE
UPC
Batch AM211171

Units Affected

1 unit

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