Actavis Recalls Fentanyl Transdermal Systems Due to Subpotent Product
Actavis is recalling Fentanyl Transdermal Systems, 100 mcg/h, because some patches may not contain fentanyl gel. The recall covers 98,088 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm or hospitalization reports are classified as Severe (Score 4).
Plain-English summary
Actavis is voluntarily recalling Fentanyl Transdermal Systems, 100 mcg/h, manufactured by Watson Laboratories Inc. The recall affects 98,088 cartons, with each carton containing five pouches. The product is identified by lot number 455040A for cartons and 455040 for pouches, and was distributed nationwide.
The recall was initiated because the product is subpotent, meaning some patches may not contain the fentanyl gel required for therapeutic effect. This defect could result in patients not receiving the intended dose of medication.
Patients and healthcare providers should check their inventory for the specific lot numbers listed. If the product is found, it should be discontinued and returned to the pharmacy or distributor for replacement or refund. Consumers should consult their healthcare provider for alternative pain management options if they are currently using this product.
The recalled product
- Product
- 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…
- Manufacturer
- Actavis
- Category
- Drug — Transdermal Patch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 455040A (carton) 455040 (pouch)
Distribution
Distributed nationwide across the United States.
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