FDA recall D-0003-2021

Product

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.

Reason for recall

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

Distribution

Nationwide in the U.S. and PR

Key facts

Status

Terminated

Initiation date

2020-09-04

Report date

2020-10-07

Termination date

2021-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2021