Drug product
Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
D-0678-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,989 tubes
- Official record key
drug-enforcement:D-0678-2022
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) 15496, Exp. 4/30/2022; 16347, Exp. 1/31/2023; b) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023; c) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations