Status
Terminated
Drug Enforcement D-0465-2023
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Classification
Class III
Report Date
March 22, 2023
Termination Date
April 30, 2024
Product Information
- 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
- Product quantity
- 11,520 cartons
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- Address
-
3250 Commerce Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0465-2023
- Event ID
- 91712
- Recall initiation date
- February 15, 2023
- Center classification date
- March 14, 2023
- Code info
- Lot#: 51835 Exp: 06/2023
- More code info
- —