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.
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 delivers clonidine through the skin to treat high blood pressure and certain other conditions.
CGMP deviations indicate an unapproved raw material was used in production, which could affect drug quality and safety.
This recall is not described as part of a broader industry pattern in the provided data.
No targeted injuries reported in the notice; however, the recall emphasizes quality control risk and potential unsafe drug product.
NDC numbers printed on carton and pouch; lot numbers on carton seals and foil packaging
No remediation timeframe provided in the notice; expect recall communications by Teva and FDA updates
Keep recall notice, lot numbers, expiration dates, and any correspondence with manufacturer.
Brand: CLONIDINE TRANSDERMAL SYSTEM. Manufacturer: Actavis Laboratories UT Inc., Salt Lake City, UT 84108. Distributor: Teva Pharmaceuticals USA, Inc. NDC 0591-3510-04 carton, 0591-3510-54 pouch. Quantity: 113,943 cartons. Form: 0.3 mg/day transdermal system. Pack: cartons of 4 Systems and 4 Adhesive Covers. Route: Rx only. Distribution: Within the U.S. Models/lot information in play: Lot 100053892 (Exp. 04/2026), Lot 100057899 (Exp. 05/2026), Lot 100062704 (Exp. 02/2027). Dates: Recall date 2026-03-19. Status: ACTIVE.
No specific injuries or incidents are described in the provided recall notice.
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