D-0466-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2023
- Initiation Date
- February 15, 2023
- Termination Date
- April 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,208 cartons
Product Description
Buprenorphine Transdermal System, CIII 20 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 60505-7079-05
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.
Distribution Pattern
Nationwide
Code Information
Lot#: 51836 Exp: 07/2023