Drug & medication recalls

Teva Pharmaceuticals USA recalls Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceut…

Recall date
June 29, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0984-2017
FDA classification
Class III
Brand / firm
Teva Pharmaceuticals USA
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56

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