Why it was recalled
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Product description
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Lot numbers, UPCs & expiration codes
Lot #: 36924, Exp 6/2021
Where it was sold
USA nationwide.
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-0649-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2021
- FDA report date
- Jul 14, 2021
- Quantity
- 9,696 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-0649-2021, exactly as published.
Show all FDA fields
- City
- Morristown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87372
- Address
- 44 Whippany Rd Ste 107
- Code information
- Lot #: 36924, Exp 6/2021
- Postal code
- 07960-4558
- Report date
- Jul 14, 2021
- Product type
- Drugs
- Recall number
- D-0649-2021
- Classification
- Class II
- Recalling firm
- Alvogen, Inc
- Product quantity
- 9,696 cartons
- Termination date
- Feb 16, 2022
- Reason for recall
- Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Feb 26, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2021