Drug product
Clonidine Transdermal System, USP, 0.3 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 0591-3510-04 carton, NDC 0591-3510-54 pouch
D-0474-2026
Product summary
- Event
- Event 98614
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 113,943 Cartons
- Official record key
drug-enforcement:D-0474-2026
Official wording
Reason: CGMP Deviations: use of an unapproved raw material
Code information: Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Distribution pattern: Within U.S
Derived failure modes
-
Manufacturing or process control
CGMP Deviations