Reported Jul 26, 2017 · Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only
- Distributed ByTeva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
- Lot codes and dates
Lot #: 30227649A30227650A30227651A30227652A30227653A30227654A30227655A30227832A30227833A30227834A30227835AEXP 06/201730228561A30228562A30228563A30228564A30228565A30228566A30228567A30228568A30228569A30228570AEXP 9/201730001243000125EXP 7/2018300039230003933000394EXP 9/201830008723000874EXP 10/2018
- Amount recalled
- 196275 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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