Recalls / Class II
Class IID-0794-2022
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
- Affected lot / code info
- 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.
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 353964 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-04-15
- FDA classified
- 2022-04-27
- Posted by FDA
- 2022-05-04
- Terminated
- 2023-05-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0794-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.