FDA Drug recall D-599-2013
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx on…
- FDA Drug
- Class III
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class III recall of Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx on… by Actavis, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-599-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-06-03 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
Product
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Reason
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot #: Patch 453658; Carton 453658A, Exp 09/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-599-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.