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Recall Observatory FDA recall evidence

Drug 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

D-0235-2022

October 28, 2021

Class III

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88938
Status
Terminated
Classification
Class III
Quantity
64,978 patches
Official record key
drug-enforcement:D-0235-2022

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot# 1369117B, exp. date 11/2021

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications