Drug product
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65
D-0850-2022
Product summary
- Event
- Event 89986
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 55,440 tubes
- Official record key
drug-enforcement:D-0850-2022
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: Lot: 15644, Exp.: 05/31/2022
Distribution pattern: Nationwide in the United States including Guam and the Northern Mariana Islands.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations