Recalls / Class II
Class IID-1492-2020
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
- Brand name
- Lidocaine
- Generic name
- Lidocaine
- Active ingredient
- Lidocaine
- Route
- Topical
- NDC
- 0591-3525
- FDA application
- ANDA200675
- Affected lot / code info
- Carton Lot # 1383513B, Patch Lot # 1383513, Exp date 03/2022
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 28,596 cartons
- Distribution pattern
- Nationwide United States
Timeline
- Recall initiated
- 2020-07-14
- FDA classified
- 2020-08-10
- Posted by FDA
- 2020-08-19
- Terminated
- 2021-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1492-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.