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Class II · ModerateRecall completed

Clonazepam Orally Disintegrating Tablets USP

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 34033752A, EXP 1/2020
Where it was soldProduct was distributed throughout the United States to various distributors who may have further distributed the product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forTeva Pharmaceuticals USA
NDC0555-0098-96
Show the full FDA record
Full product labelClonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Recalling firmTeva Pharmaceuticals USA
DistributionProduct was distributed throughout the United States to various distributors who may have further distributed the product.
Quantity1,373 60-count cartons
Recall initiated2018-09-20
Report date2018-10-24
Recall completed2019-11-07
Recall numberD-0082-2019
ClassificationClass II
FDA statusTerminated
Origin on fileNorth Wales PA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.