Teva Pharmaceuticals USA recalls Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured b…

Recall date

September 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0003-2021

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide in the U.S. and PR

Why it was recalled

Failed Stability Specifications: Below specification result for buprenorphine release rate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.