Drug product
Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
D-0675-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,426 tubes
- Official record key
drug-enforcement:D-0675-2022
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) 15495, Exp. 4/30/2022; 16955, Exp. 5/31/2023; b) 15249, 15250, 15446, Exp. 3/31/2022; 15495, Exp. 4/30/2022; 16377, Exp. 1/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations