Safety Alerts & Recalls

What does this mean?

Since Dextroamphetamine/Amphetamine has serious side effects if overdosed, this recall should be taken seriously. These side effects may include fast heart rate, high blood pressure, tremors, decreased appetite, headache, insomnia, dizziness, agitation and other changes in behavior, blurred vision, stomach upset, and dry mouth.

If you are, or someone you care for is taking Dextroamphetamine/Amphetamine, look at your prescription to see if it is 20mg tablets manufactured by Barr Laboratories. The manufacturer is often listed on the prescription label. Or, you can look at the tablets and see if they have any of the following "Barr" markings: The Barr Laboratories Dextroamphetamine/Amphetamine 20mg tablet is an oval peach colored tablet with b/973 on one side and 2/0 on the other side.

If you think your tablets are made by Barr Laboratories and are involved in the recall, you should return them to your pharmacy immediately to examine and possibly exchange. If you are not sure who has made your tablets, please take your bottle to your pharmacist for them to check as soon as possible.

If you have any other questions about the recall or if you are concerned about side effects, you should contact your physician, pharmacist, or other health care provider. You can also contact Barr Laboratories for more information about the recall at 888-742-5578 from 8:00am - 8:00pm Eastern Daylight Time (EDT) Monday-Friday.

Recall on Single Lot of Barr Laboratories Brand Dextroamphetamine/Amphetamine 20mg Tablets

Barr Laboratories, Inc. has recalled a single lot of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (mixed amphetamine salts) 20mg tablets. The lot number involved in the recall is lot number 311756. The affected lot was available to patients after June 11, 2009.

These tablets may be oversized and contain more drug than appropriate. This could result in patients receiving more than the expected dosage of this drug.

Dextroamphetamine/Amphetamine is used in the treatment of narcolepsy and attention deficit disorder and is also known by the brand names Adderall and Adderall XR. However, Barr Laboratories lot number 311756 is the only lot involved and no other lot numbers, strengths, or brands of Dextroamphetamine/Amphetamine are affected by this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-08-14
Last Updated: 2009-08-14

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