Home / Recalls / Actavis / D-599-2013

D-599-2013 Class III Terminated

Recalled by Actavis — Salt Lake City, UT

FDA drug recall D-599-2013 was initiated by Actavis on Jun 3, 2013 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Apr 9, 2014). Affected quantity: 98,952 boxes.

Recall details

Product Type: Drugs
Report Date: Jun 19, 2013
Initiation Date: Jun 3, 2013
Termination Date: Apr 9, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 98,952 boxes

Product description

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

Distribution pattern

Nationwide

Code information

Lot #: Patch 453658; Carton 453658A, Exp 09/13

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-599-2013
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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