Upsher-Smith Laboratories, LLC
Overview
Upsher-Smith Laboratories, LLC is a pharmaceutical company dedicated to developing and delivering therapies to enhance health and well-being. As a subsidiary of Japan-based Sawai Pharmaceutical Co., Ltd., Upsher-Smith focuses on providing high-quality generic and branded pharmaceuticals.
Therapeutic areas
API / Drug Master Files
Upsher-Smith Laboratories, LLC holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS)Inactive1993-10-07
FDA compliance signals
8 FDA enforcement records linked to this company.
- 4832025-08-08
Failure to develop written procedures
- 4832025-08-08
Late submission of 15-day report
- recall — Class II2019-08-28
Failed Dissolution Specifications
- recall — Class II2018-10-31
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- recall — Class II2018-10-31
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- recall — Class III2014-04-30
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
- recall — Class II2013-02-20
Failed Dissolution Test Requirements
- recall — Class III2013-01-23
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
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