Lidocaine Patch
FDA Recall NDC 0591-3525
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Lidocaine (NDC 0591-3525). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Actavis Pharma, Inc.. The reported reason for this action was: "cGMP deviations: Temperature abuse"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
1 carton/30 pouches
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0591-3525-11Product
0591-3525-30Product
Class II Terminated
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Jul 14, 2020
Aug 19, 2020
28,596 cartons
Recall Profile & Regulatory Data
Event ID
86017
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide United States
Termination Date
Jul 07, 2021
Product Description
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
Affected Packages Involved in this Recall
0591-3525-11Product
0591-3525-30Product
Class III Terminated
Failed Stability Specifications
Apr 30, 2018
May 30, 2018
30,382 patches
Recall Profile & Regulatory Data
Event ID
80004
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Termination Date
Jan 14, 2019
Product Description
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
0591-3525-11Product
0591-3525-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
