Drug product
Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
D-0677-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54,897 tubes
- Official record key
drug-enforcement:D-0677-2022
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) 15196, Exp. 2/28/2022; 16605, Exp. 3/31/2023; b)15190, Exp. 2/28/2022; 16660, Exp. 4/30/2023; 17037, Exp. 6/30/2023; 17163, Exp. 8/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations