Drug product
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
D-0673-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72,826 tubes
- Official record key
drug-enforcement:D-0673-2022
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) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; b) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; 17046, Exp. 6/30/2023; c) 15856, Exp. 8/31/2022; d) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations