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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

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.
Recall Number D-1693-2012
Classification Class II
Code Info Lot number 455040A (carton) 455040 (pouch)
Product Distributed Qty 98,088 cartons (5 pouches per carton)
Reason For Recall Subpotent; some patches may not contain fentanyl gel

Event Detail

Event Id 62384
Product Type Drugs
Status Ongoing
Recalling Firm Watson Laboratories, Inc.
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide