FDA-Drug2023-03-22Class III
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
AVEVA Drug Delivery Systems, Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Sold states
Nationwide
Affected count
11,520 cartons
Manufactured in
3250 Commerce Pkwy, N/A, Miramar, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0465-2023Don't want to check this manually?
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