D-0794-2022 Class II Terminated
FDA drug recall D-0794-2022 was initiated by Teva Pharmaceuticals USA Inc on Apr 15, 2022 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated May 25, 2023). Affected quantity: 353964 units.
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 15, 2022
- Termination Date
- May 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 353964 units
Product Description
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
Reason for Recall
cGMP Deviations
Distribution Pattern
Nationwide within the United States
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0794-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026