Recalls / Class I
Class ID-1277-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Fentanyl System
- Generic name
- Fentanyl
- Active ingredient
- Fentanyl
- Route
- Transdermal
- NDCs
- 47781-423, 47781-424, 47781-426, 47781-427, 47781-428
- FDA application
- ANDA202097
- Affected lot / code info
- Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Why it was recalled
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.
Recalling firm
- Firm
- Alvogen, Inc
- Manufacturer
- ALVOGEN
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, New Jersey 07058-9743
Distribution
- Quantity
- 119,608 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-19
- FDA classified
- 2019-05-13
- Posted by FDA
- 2019-05-15
- Terminated
- 2019-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1277-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.