Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Product description
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
Lot numbers, UPCs & expiration codes
Lot#: 51835 Exp: 06/2023
Where it was sold
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-0465-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 15, 2023
- FDA report date
- Mar 22, 2023
- Quantity
- 11,520 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
Original FDA data
Every field from FDA enforcement report D-0465-2023, exactly as published.
Show all FDA fields
- City
- Miramar
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 91712
- Address
- 3250 Commerce Pkwy
- Code information
- Lot#: 51835 Exp: 06/2023
- Postal code
- 33025-3907
- Report date
- Mar 22, 2023
- Product type
- Drugs
- Recall number
- D-0465-2023
- Classification
- Class III
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- Product quantity
- 11,520 cartons
- Termination date
- Apr 30, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 15, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2023