Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manu
Summary
The FDA issued a Class III for Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One pa by AVEVA Drug Delivery Systems, Inc.. Reason: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-.
Details
Source
Drug Recall
External ID
D-0465-2023
Action Date
2023-03-22
Status
Terminated
Category
drug
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/Code Info: Lot#: 51835 Exp: 06/2023
Quantity Affected: 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.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-15
Company
Miramar, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AVEVA Drug Delivery Systems, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVEVA Drug Delivery Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVEVA Drug Delivery Systems, Inc. have FDA actions?
AVEVA Drug Delivery Systems, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0465-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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