Drug product
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
D-0669-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,218 bottles
- Official record key
drug-enforcement:D-0669-2022
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) 15998, Exp. 3/31/2022; b) 16104, Exp. 4/30/2022; 16133, Exp. 5/31/2022; 16391, Exp. 8/31/2022; 15440, Exp. 9/30/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations