Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Lot numbers, UPCs & expiration codes
Lot# 1369117B, exp. date 11/2021
Where it was sold
Nationwide and Puerto Rico
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-0235-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 28, 2021
- FDA report date
- Nov 24, 2021
- Quantity
- 64,978 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0235-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88938
- Address
- 400 Interpace Pkwy
- Code information
- Lot# 1369117B, exp. date 11/2021
- Postal code
- 07054-1120
- Report date
- Nov 24, 2021
- Product type
- Drugs
- Recall number
- D-0235-2022
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 64,978 patches
- Termination date
- Feb 27, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 28, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2021