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 #: 34034024B
    • Exp 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 1, 2019 · Data as of Sep 19, 6:37 PM UTC

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