FDA DrugsClass II
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems ...
Published: April 15, 2026Recall ID: D-0472-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations: use of an unapproved raw material
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Parsippany |
| State | NJ |
| Openfda › Nui › 1 | N0000009918 |
| Openfda › Nui › 2 | N0000175554 |
| Openfda › Unii | MN3L5RMN02 |
| Openfda › Route | TRANSDERMAL |
| Openfda › Rxcui › 1 | 998671 |
| Openfda › Rxcui › 2 | 998675 |
| Openfda › Rxcui › 3 | 998679 |
| Openfda › Spl id | 996f475b-4f8b-4487-b5c1-6e5c4f284045 |
| Openfda › Brand name | CLONIDINE TRANSDERMAL SYSTEM |
| Openfda › Spl set id | 99a59495-2a48-4276-bbe3-cdd55a45aba4 |
| Openfda › Package ndc › 1 | 0591-3508-54 |
| Openfda › Package ndc › 2 | 0591-3508-04 |
| Openfda › Package ndc › 3 | 0591-3509-54 |
| Openfda › Package ndc › 4 | 0591-3509-04 |
| Openfda › Package ndc › 5 | 0591-3510-54 |
| Openfda › Package ndc › 6 | 0591-3510-04 |
| Openfda › Product ndc › 1 | 0591-3508 |
| Openfda › Product ndc › 2 | 0591-3509 |
| Openfda › Product ndc › 3 | 0591-3510 |
| Openfda › Generic name | CLONIDINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | CLONIDINE |
| Openfda › Pharm class epc | Central alpha-2 Adrenergic Agonist [EPC] |
| Openfda › Pharm class moa | Adrenergic alpha2-Agonists [MoA] |
| Openfda › Manufacturer name | Actavis Pharma, Inc. |
| Openfda › Application number | ANDA090873 |
| Openfda › Is original packager | true |
| Event id | 98614 |
| Address 1 | 400 Interpace Pkwy Bldg A |
| Code info | Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. |
| Postal code | 07054-1120 |
| Report date | 20260415 |
| Product type | Drugs |
| Product quantity | 124,054 Cartons |
| Reason for recall | CGMP Deviations: use of an unapproved raw material |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Letter |
| Center classification date | 20260413 |
Overview
- Recalling FirmTeva Pharmaceuticals USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWithin U.S