Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
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
Lot numbers, UPCs & expiration codes
Carton Lot # 1383513B, Patch Lot # 1383513, Exp date 03/2022
Where it was sold
Nationwide United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1492-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- 28,596 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1492-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86017
- Address
- 400 Interpace Pkwy
- Code information
- Carton Lot # 1383513B, Patch Lot # 1383513, Exp date 03/2022
- Postal code
- 07054-1120
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1492-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 28,596 cartons
- Termination date
- Jul 7, 2021
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide United States
- Recall initiation date
- Jul 14, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2020