July 2020 FDA Recall Lidocaine by Teva Pharmaceuticals Usa
D-1492-2020 - Labeling
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on July 14, 2020 for the product Lidocaine. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1492-2020
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
07-14-2020
08-19-2020
28,596 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide United States
07-07-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30
Batch or Lot Expiration Information
Lot# Carton
Lot# 1383513B, Patch
Lot# 1383513, Exp date 03/2022
