Reported Mar 22, 2023 · Terminated
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only,…
AVEVA Drug Delivery Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AVEVA Drug Delivery Systems, Inc. · 3250 Commerce Pkwy · Miramar, FL · 33025-3907
Is this the product you have?
- Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only
- Manufactured byAveva Drug Delivery Systems Inc. Miramar, FL. 33025
- Manufactured for
Apotex Corp WestonFL. 33326NDC 60505-7077-05
- Lot codes and dates
- Lot#: 51835
- Exp06/2023
- Amount recalled
- 11,520 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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