April 2022 FDA Recall Drug by Teva Pharmaceuticals Usa Inc
D-0794-2022 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on April 15, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0794-2022

Reason for Recall
cGMP Deviations
Initiated
04-15-2022
Reported
05-04-2022
Quantity
353964 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89944
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-25-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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.