Drug product
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
D-0676-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6850 tubes
- Official record key
drug-enforcement:D-0676-2022
Official wording
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Code information: Batch: 15996, 15997, Exp. 9/30/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations