D-0866-2020 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

FDA drug recall D-0866-2020 was initiated by Lupin Pharmaceuticals Inc. on February 19, 2020 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specification; high out of specification results observed The recall status is terminated (terminated June 3, 2021). Affected quantity: 876 bottles.

Recall Details

Product Type
Drugs
Report Date
March 11, 2020
Initiation Date
February 19, 2020
Termination Date
June 3, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
876 bottles

Product Description

Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD

Reason for Recall

Failed Impurities/Degradation Specification; high out of specification results observed

Distribution Pattern

Product was distributed throughout the United States.

Code Information

K800475 exp. date May 2020 K800477 exp. date June 2020