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Upsher Smith Laboratories, Inc.

Upsher Smith Laboratories, Inc. Recalls

All product recalls associated with Upsher Smith Laboratories, Inc..

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Recall Summary

Total Recalls

6

Past Year

0

Class I (Serious)

0

Most Recent

Jul 2019

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–6 of 6 recalls

Bexarotene Capsules (Upsher Smith) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2019KY, LA, NJ +1 more• Upsher Smith Laboratories, Inc.

Bumetanide 2mg (Upsher Smith) – Impurity Specification (2018)

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Class IIModerate

FDASep 19, 2018Nationwide• Upsher Smith Laboratories, Inc.

Bumetanide 1mg (Upsher Smith) – Impurity Specification (2018)

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Moderate

FDASep 19, 2018Nationwide• Upsher Smith Laboratories, Inc.

Oxandrolone Tablets (Upsher Smith) – missing primary label (2014)

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.

FDAApr 14, 2014Nationwide• Upsher Smith Laboratories, Inc.

Divalproex Sodium Tablets (Upsher Smith) – Labeling Error (2012)

Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

FDADec 10, 2012Nationwide• Upsher Smith Laboratories, Inc.

Propranolol Extended-release Capsules (Upsher) – dissolution failure (2012)

Failed Dissolution Test Requirements

Class IIModerate

FDANov 20, 2012FL, NJ• Upsher Smith Laboratories, Inc.