Drug product
Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
D-0689-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 161,331 tubes
- Official record key
drug-enforcement:D-0689-2022
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) 15280, Exp. 2/28/2022; 16539, Exp. 3/31/2023; 16907, Exp. 5/31/2023; b) 15381, Exp. 3/31/2022; 15382, 15501, 15523, Exp. 4/30/2022; 15812, Exp. 7/31/2022; 15972, 16034, 16037, Exp. 9/30/2022; 16105, 16143, Exp. 10/31/2022; 16539, 16746, 16747, Exp. 3/31/2023; 16906, Exp. 5/31/2023; 16962, 17041, Exp. 6/30/2023; 17110, Exp. 7/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations