FDA-Drug2020-10-07Class II
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Teva Pharmaceuticals USA
Hazard
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Sold states
Nationwide in the U.S. and PR
Affected count
32,543 cartons
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2021Don't want to check this manually?
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