Drug product
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
D-0672-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,180 bottles
- Official record key
drug-enforcement:D-0672-2022
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) 15599, Exp. 4/30/2022; 16108, Exp. 10/31/2022; 16471, Exp. 2/28/2023; 16680, Exp. 3/31/2023; b) 15120, 15126, 15592, Exp. 2/28/2022; 15599, Exp. 4/30/2022; 16108, 16145, Exp. 10/31/2022; 16261, Exp. 12/31/2022; 16456, 16471, Exp. 2/28/2023; 16552, 16680, Exp. 3/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations