Drug product
Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
D-0847-2022
Product summary
- Event
- Event 89986
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13, 200 tubes
- Official record key
drug-enforcement:D-0847-2022
Official wording
Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Code information: Lots: 15720, Exp.: 06/30/2022; 16449 Exp.: 02/28/2023; 16450, Exp.: 02/26/2023
Distribution pattern: Nationwide in the United States including Guam and the Northern Mariana Islands.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations