CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch. Generic: CLONIDINE; Brand: CLONIDINE TRANSDERMAL SYSTEM. Reason: CGMP Deviations: use of an unapproved raw material. Classification: Class II. Quantity: 62,136 Cartons. Distribution: Within U.S
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Teva-affiliated Clonidine Transdermal System recalls 113,943 cartons after CGMP deviations. Unapproved raw material prompts recall. Stop use immediately and contact Teva or a healthcare provider for guidance.
Teva Pharmaceuticals recalled 124,054 cartons of Clonidine Transdermal System due to CGMP deviations from an unapproved raw material. The recall affects products sold in the United States. Consumers should stop using the product immediately and consult a healthcare provider for guidance.
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