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Recall Observatory FDA recall evidence

Drug 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

D-0983-2017

June 29, 2017

Class III

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 77725
Status
Terminated
Classification
Class III
Quantity
25264 bottles
Official record key
drug-enforcement:D-0983-2017

Official wording

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

Code information: Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification