Drug product
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.
D-0701-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4532 tubes
- Official record key
drug-enforcement:D-0701-2022
Official wording
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Code information: Batch: 15876, Exp 8/31/2022; 16205, Exp. 11/30/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations