D-1497-2020 Class III Terminated
FDA drug recall D-1497-2020 was initiated by Golden State Medical Supply Inc. on Jul 24, 2020 and is designated Class III. Reason for recall: Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. The recall status is terminated (terminated Dec 10, 2020).
Recall details
- Product Type
- Drugs
- Report Date
- Aug 19, 2020
- Initiation Date
- Jul 24, 2020
- Termination Date
- Dec 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
Reason for recall
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Distribution pattern
Nationwide within the United States
Code information
Lot #: a) AB28535, Exp. Date: Dec. 2021 b) AB40178, Exp. Date: Dec. 2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1497-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026