Drug product
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
D-0684-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,748 tubes
- Official record key
drug-enforcement:D-0684-2022
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) 15122, Exp. 2/28/2022; 15475, Exp. 3/31/2022; b) 15119, Exp. 2/28/2022; 15122, Exp. 2/28/2022; 15380, Exp. 3/31/2022; c) 15380, Exp. 3/31/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations