FlaggedRx← Medication recall checkHome
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#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17
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 Clonazepam Related Compound (RC) A (a known impurity) at 15 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)
NDC51079-881-20
Show the full FDA record
Full product labelClonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)
DistributionNationwide
Quantity1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)
Recall initiated2016-09-28
Report date2016-11-16
Recall completed2018-08-28
Recall numberD-0135-2017
ClassificationClass III
FDA statusTerminated
Origin on fileRockford IL United States

Related

Clonazepam recallsRecent drug recallsCheck another medication

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.