Maple Grove, MN, United States
Upsher Smith Laboratories, Inc. recalls
2 recalls recorded since 2018, most recently on 29 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 29 July 2019
- Terminated
- 25 August 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- KY, OH, NJ, LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1836-2019
- Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
Terminated Class II Drugs
- Recall started
- 19 September 2018
- Terminated
- 30 September 2020
- Reason
- Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- Distribution
- Nationwide USA, Puerto Rico and Guam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0281-2019, D-0280-2019
- Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
- Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.