Drug product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, 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 63739-977-64
D-0848-2022
Product summary
- Event
- Event 89986
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 81,757 bottles
- Official record key
drug-enforcement:D-0848-2022
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: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024
Distribution pattern: Nationwide in the United States including Guam and the Northern Mariana Islands.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations