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Class III · Lower riskRecall completed

Clonazepam Tablets

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # 3063759, Exp.07/16
Where it was soldNationwide
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 Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

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

Made byMylan Pharmaceuticals Inc., Morgantown, WV, 26505
Distributed by / forMylan Institutional, Inc. (d.b.a. UDL Laboratories)
NDC51079-881-21
Show the full FDA record
Full product labelClonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)
DistributionNationwide
Quantity868 unit cartons (86,800 tablets)
Recall initiated2016-01-28
Report date2016-02-10
Recall completed2016-12-21
Recall numberD-0650-2016
ClassificationClass III
FDA statusTerminated
Origin on fileRockford IL United States

Related

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.