Safety Alerts & Recalls

What does this mean?

Incorrectly sized tablets can lead to problems or side effects of receiving too high or too low of a dose. Side effects of too much clonazepam include drowsiness, dizziness, unsteadiness, problems with coordination, and difficulty thinking or remembering. If you take recalled tablets that contain a lower dose than labeled, you may experience withdrawal symptoms such as new or worsening seizures, hallucinating (seeing things or hearing voices that do not exist), changes in behavior, sweating, uncontrollable shaking of a part of your body, stomach or muscle cramps, anxiety, or difficulty falling asleep or staying asleep.

If you take clonazepam 0.5 mg or 1 mg, check your prescription bottle to see if your tablets were made by Teva Pharmaceuticals or Novopharm Ltd. and is labeled with one of the product NDC numbers listed in the recall. The manufacturer and the product NDC number is often listed on the prescription label. If you think your tablets may be involved in the recall, or if you do not know, please return your bottle to your pharmacist to examine and possibly exchange.

If you have any questions or concerns about this recall, please follow up with your doctor or pharmacist. If you think you may be experiencing side effects from clonazepam, please contact your doctor as soon as possible.

Recall on Several Lots of Teva / Novopharm Clonazepam 0.5 mg and 1 mg Tablets

Teva Pharmaceuticals and Novopharm Ltd. are recalling several lots of Clonazepam 0.5 mg and 1 mg tablets. These lots are being recalled because the tablets do not meet manufacturing standards for size and potency of the tablet. The product NDC numbers and the lot numbers involved in this recall include the following: 1) Clonazepam Tablets, 0.5 mg with product code NDC 0093-0832-01 or NDC 0093-0832-05

Lot numbers: 35200435A exp 9/2010, 35200408A exp 9/2010, 35200409A exp 9/2010, 35200436A exp 9/2010, 35200437A exp 9/2010, 35200460A exp 9/2010, 35200462A exp 9/2010, and 35200438A exp 9/2010

2) Clonazepam Tablets ,1 mg with a product code NDC 0093-0833-01, NDC 0093-0833-05, or NDC 0093-0833-10

Lot numbers: 35200199A exp 2/2010, 35200200A exp 2/2010, 35200201A exp 2/2010, 35200218A exp 2/2010, 35200219A exp 2/2010, 35200278A exp 2/2010, 35200202A exp 2/2010, 35200248A exp 2/2010, 35200220A exp 2/2010 and 35200203A exp 2/2010

Clonazepam is primarily used for the treatment of seizures and panic disorders. It is also sold under the brand name Klonopin. No other brands or strengths of clonazepam were involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-11-12
Last Updated: 2009-12-05

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