FDA MedWatch Alerts
Printable Version   Email to a friend

Fentanyl Transdermal System CII Patches

August 12, 2008
Audience: Pain management specialists, risk managers, other healthcare professionals, patients
[UPDATED 08/12/2008] Watson Pharmaceuticals, Inc., issued a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches (lot 92461850; Expiration Date: 8/31/2009) sold in the United States between January 30, 2008, and March 19, 2008. The product was recalled because a small number of the patches were leaking and may expose patients or caregivers directly to fentanyl gel.

[UPDATED 03/03/2008] Actavis Inc. has voluntarily recalled of all lots of Fentanyl Transdermal System CII patches sold in the United States.

[Posted 02/19/2008] Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labelled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press release.

[August 08, 2008 - Press Release - Watson]
[March 01, 2008 - Press Release - Actavis]
[February 17, 2008 - Press Release - Actavis]

Latest FDA MedWatch Alerts...

FDA MedWatch Alerts Archive

2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2002: Feb | Mar | Apr | May | Jun | Jul | Sep | Oct | Nov

More News Resources


MedNotes
Latest Drug Information Updates

Promacta
Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.

Banzel
Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Apriso
Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

LoSeasonique
LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Acanya
Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

Toviaz
Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Vimpat
Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.

Astepro
Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

Rapaflo
Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.

Cinryze
Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Akten
Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

AdreView
AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

Sancuso
Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

Nplate
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Xenazine
Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

More...