Recalls / Class III
Class IIID-0235-2022
Product
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
- Brand name
- Clonidine Transdermal System
- Generic name
- Clonidine
- Active ingredient
- Clonidine
- Route
- Transdermal
- NDCs
- 0591-3508, 0591-3509, 0591-3510
- FDA application
- ANDA090873
- Affected lot / code info
- Lot# 1369117B, exp. date 11/2021
Why it was recalled
Failed Impurities/Degradation Specifications
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
- 64,978 patches
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2021-10-28
- FDA classified
- 2021-11-16
- Posted by FDA
- 2021-11-24
- Terminated
- 2023-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0235-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.