FDAFDA · Food and drugs·Recall number D-0171-2024
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
Published January 3, 2024 · Recall initiated: January 26, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CARDINAL HEALTHCARE
- Distributor
- Nationwide USA
- Lot
- Batch AM211171
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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