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.

FDA recall notice · announced June 19, 2013 · Actavis

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide
Lot/code information: Lot #: Patch 453658; Carton 453658A, Exp 09/13
Quantity: 98,952 boxes
Status: Terminated
Products in this recall event:
- 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, 928 (D-599-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.