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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1277-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 19, 2019
- FDA report date
- May 15, 2019
- Quantity
- 119,608 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-1277-2019, exactly as published.
Show all FDA fields
- City
- Pine Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82669
- Address
- 10 Bloomfield Ave Bldg B Ste 2
- Code information
- Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
- Postal code
- 07058-9743
- Report date
- May 15, 2019
- Product type
- Drugs
- Recall number
- D-1277-2019
- Classification
- Class I
- Recalling firm
- Alvogen, Inc
- Product quantity
- 119,608 cartons
- Termination date
- Aug 14, 2019
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 19, 2019
- Initial firm notification
- Press Release
- Center classification date
- May 13, 2019