Drug product
Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
D-0849-2022
Product summary
- Event
- Event 89986
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1176 tubes
- Official record key
drug-enforcement:D-0849-2022
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: 16876, Exp.: 05/31/2023
Distribution pattern: Nationwide in the United States including Guam and the Northern Mariana Islands.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations