Reported Oct 10, 2018 · Terminated
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
- Lot codes and dates
Lot #: 34034024BExp 02/20
- Amount recalled
- 313 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
This product could cause temporary or reversible health problems — stop using it.
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