Drug product
Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
D-0674-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81,883 tubes
- Official record key
drug-enforcement:D-0674-2022
Official wording
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Code information: Batch: a) 15063, Exp. 2/28/2022; 15928, Exp. 9/30/2022; 16432, Exp. 2/28/2023; 16769, Exp. 4/30/2023; b) 15243, Exp. 2/28/2022; 16628, Exp. 3/31/2023; c) 15064, 15286, 15287, Exp. 2/28/2022; 16173, Exp. 11/30/2022; 16628, Exp. 3/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations