Home / Recalls / Upsher Smith Laboratories, Inc. / D-0280-2019

D-0280-2019 Class II Terminated

Recalled by Upsher Smith Laboratories, Inc. — Maple Grove, MN

Recall Details

Product Type
Drugs
Report Date
October 31, 2018
Initiation Date
September 19, 2018
Termination Date
September 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,764 bottles

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.

Distribution Pattern

Nationwide USA, Puerto Rico and Guam

Code Information

Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020

Other recalls by Upsher Smith Laboratories, Inc.

  • D-1836-2019 Class II — Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: (July 29, 2019)
  • D-0281-2019 Class II — Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upse (September 19, 2018)
  • D-1255-2014 Class III — Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured f (April 14, 2014)
  • D-127-2013 Class III — Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 1 (December 10, 2012)
  • D-160-2013 Class II — Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, R (November 20, 2012)