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Recall Observatory FDA recall evidence

Drug 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

D-1492-2020

July 14, 2020

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 86017
Status
Terminated
Classification
Class II
Quantity
28,596 cartons
Official record key
drug-enforcement:D-1492-2020

Official wording

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

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

Distribution pattern: Nationwide United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing