FDA recall D-1325-2014

Teva Pharmaceuticals USA · Class II · drug

Product

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-04-07
Report date: 2014-05-28
Termination date: 2014-11-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1325-2014