FDA Recall D-1277-2019
Alvogen, Inc · Pine Brook, NJ
Class I — life-threatening Terminated 117 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
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.
Recall record
- Recall number
D-1277-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2019-04-19
- Classified by FDA Center
- 2019-05-13
- FDA published
- 2019-05-15
- Terminated
- 2019-08-14
- Recalling firm
- Alvogen, Inc
- Firm location
- Pine Brook, NJ
Drug identification
- Brand name(s)
- FENTANYL SYSTEM
- Generic name(s)
- FENTANYL
- Manufacturer(s)
- ALVOGEN
- NDC(s)
47781-423, 47781-424, 47781-426, 47781-427, 47781-428- Route(s)
- TRANSDERMAL