Drug product
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
D-0794-2022
Product summary
- Event
- Event 89944
- Status
- Terminated
- Classification
- Class II
- Quantity
- 353964 units
- Official record key
drug-enforcement:D-0794-2022
Official wording
Reason: cGMP Deviations
Code information: Lot #: a) 16291, Exp. Date 01/2024;16469, Exp. Date 02/2024; b)16255, Exp. Date 11/2022; 16256, 16412 Exp. Date 02/2024; 16257, 16258, Exp. Date12/2022; 16505, 6506, Exp. Date 03/2024; 16627,16786, 16787,16820, Exp. Date 04/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations