Drug Enforcement D-1693-2012

Subpotent; some patches may not contain fentanyl gel

Status

Terminated

Classification

Class II

Report Date

October 3, 2012

Termination Date

April 10, 2013

Product Information

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.
Product quantity
98,088 cartons (5 pouches per carton)
Reason for recall
Subpotent; some patches may not contain fentanyl gel
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Actavis
Address
575/577/579 Chipeta Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1693-2012
Event ID
62384
Recall initiation date
July 11, 2012
Center classification date
September 25, 2012
Code info
Lot number 455040A (carton) 455040 (pouch)
More code info
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