FDAClass IIAugust 19, 2020

Lidocaine Patch 5% recall: Labeling Error

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

Why was Lidocaine Patch 5% recalled?

Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Carton Lot # 1383513B, Patch Lot # 1383513, Exp date 03/2022

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
Recalling firm
Teva Pharmaceuticals USA
Quantity
28,596 cartons
Distribution
Nationwide United States
Recall date
August 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls