April 2018 FDA Recall Lidocaine by Teva Pharmaceuticals Usa
D-0857-2018 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on April 30, 2018 for the product Lidocaine. The FDA reported the reason for recall as failed stability specifications. The product was distributed in United States and the recall is currently terminated.

Recall Number: D-0857-2018

Reason for Recall
Failed Stability Specifications
Initiated
04-30-2018
Reported
05-30-2018
Quantity
30,382 patches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80004
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
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
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the product.
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

Batch or Lot Expiration Information

Lot# Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020

Affected Packages Involved in this Recall

0591-3525-11 Lidocaine
0591-3525-30 Lidocaine