April 2019 FDA Recall Fentanyl System by Alvogen, Inc
D-1277-2019 - Product Mix-Up
This Class I drug recall was voluntarily initiated by Alvogen, Inc on April 19, 2019 for the product Fentanyl System. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1277-2019
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
04-19-2019
05-15-2019
119,608 cartons
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alvogen, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
08-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
Batch or Lot Expiration Information
Lot# : 180060, Exp 05/2020; 180073, Exp 06/2020.
