Drug product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
D-0688-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,185 tubes
- Official record key
drug-enforcement:D-0688-2022
Official wording
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Code information: Batch: 15128, Exp. 2/28/2022; 15721, Exp. 6/30/2022; 16171, Exp. 10/31/2022; 16819, Exp. 4/30/2023; 17124, Exp. 7/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations