Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Reported: October 31, 2018 Initiated: September 19, 2018 #D-0280-2019
Product Description
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Reason for Recall
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Details
- Recalling Firm
- Upsher Smith Laboratories, Inc.
- Units Affected
- 44,764 bottles
- Distribution
- Nationwide USA, Puerto Rico and Guam
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11. Recalled by Upsher Smith Laboratories, Inc.. Units affected: 44,764 bottles.
Why was this product recalled? ▼
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0280-2019.
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