FDAFDA · Food and drugs·Recall number D-0983-2017
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
Published July 26, 2017 · Recall initiated: June 29, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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