D-1497-2022 Class II Terminated
FDA drug recall D-1497-2022 was initiated by Padagis US LLC on August 17, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. The recall status is terminated (terminated September 28, 2023). Affected quantity: 57,816 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 7, 2022
- Initiation Date
- August 17, 2022
- Termination Date
- September 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57,816 tubes
Product Description
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Reason for Recall
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 2CT0486 , Exp 02/29/2024