Home / Recalls / Actavis / D-1693-2012

D-1693-2012 Class II Terminated

Recalled by Actavis — Salt Lake City, UT

FDA drug recall D-1693-2012 was initiated by Actavis on Jul 11, 2012 and is designated Class II. Reason for recall: Subpotent; some patches may not contain fentanyl gel The recall status is terminated (terminated Apr 10, 2013). Affected quantity: 98,088 cartons (5 pouches per carton).

Recall details

Product Type: Drugs
Report Date: Oct 3, 2012
Initiation Date: Jul 11, 2012
Termination Date: Apr 10, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 98,088 cartons (5 pouches per carton)

Product description

Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.

Reason for recall

Subpotent; some patches may not contain fentanyl gel

Distribution pattern

Nationwide

Code information

Lot number 455040A (carton) 455040 (pouch)

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1693-2012
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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