FDA-Drug2017-07-26Class III

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

Teva Pharmaceuticals USA
Hazard

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

Sold states
Nationwide in the USA
Affected count
25264 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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

Official notice

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

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