Key Takeaway
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 (N by Actavis was recalled on July 11, 2012. The hazard: Subpotent; some patches may not contain fentanyl gel
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 (N
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.
Hazard / Reason
Subpotent; some patches may not contain fentanyl gel
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
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 (N
DrugsDistribution
Nationwide
Related Recalls
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Coro
February 7, 2014
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
June 3, 2013
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.