Alvogen Recalls Fentanyl Transdermal Systems Due to Product Mix-Up
Alvogen is recalling Fentanyl Transdermal Systems because a customer reported a carton labeled 12 mcg/h contained 50 mcg/h patches.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Alvogen, Inc. is recalling Fentanyl Transdermal Systems, 12 mcg/h, due to a product mix-up. A customer complaint indicated that a carton labeled as containing 12 mcg/h systems actually contained five patches labeled and containing 50 mcg/h.
The recall involves 119,608 cartons of the 12 mcg/h strength, distributed nationwide in the USA. The affected lots are 180060 (Exp 05/2020) and 180073 (Exp 06/2020). The product is distributed by Alvogen, Inc., Pine Brook, NJ, and manufactured by 3M Drug Delivery Systems, St. Paul, MN.
Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If a carton labeled 12 mcg/h contains patches labeled 50 mcg/h, the product should not be used. Contact Alvogen or the prescribing physician for further instructions.
The recalled product
- Product
- FENTANYL SYSTEM (FENTANYL)
- Brand
- FENTANYL SYSTEM
- Manufacturer
- Alvogen, Inc
- Category
- Drug — Prescription Drug
- Affected units
- 119,608
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 (4)
- Lot#: 180060
- Exp 05/2020
- 180073
- Exp 06/2020.
Distribution
Distributed nationwide across the United States.
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