FDA recall D-0517-2017

Product

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-02-07

Report date

2017-03-22

Termination date

2018-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2017