D-0472-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 15, 2026
- Initiation Date
- March 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124,054 Cartons
Product Description
Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch
Reason for Recall
CGMP Deviations: use of an unapproved raw material
Distribution Pattern
Within U.S
Code Information
Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.