FDA recall D-0983-2017

Product

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

Reason for recall

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-06-29

Report date

2017-07-26

Termination date

2018-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2017