Bumetanide Tablets recall: CGMP Deviations
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
Why was Bumetanide Tablets recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch AM211171
- Product
- 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
- Recalling firm
- CARDINAL HEALTHCARE
- Quantity
- 1 unit
- Distribution
- Nationwide USA
- Recall date
- January 3, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)