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
Product summary
- 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
Labeling: Incorrect or Missing