Barr Labs Tablets Recalled, May be Oversized and Potentially Dangerous, FDA Says

Tablets made by Barr Laboratories, Inc. are being recalled because the pills may be oversized and contain potentially dangerous overdoses of the active ingredients, the Food and Drug Administration said today.

The company is recalling lot number 311756 of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) in 20mg tablets, which were sold in 100 count bottles.

People who take the oversized tablets may suffer significant adverse reactions to overdoses, including cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite, the FDA said.

So far, there have been no reports of adverse events associated with oversized of overweight Barr Labs tablets, the FDA said.

The recalled pills are oval, peach colored tablets stamped with “b/973” on one side and “2/0” on the other. They were distributed between June 11, 2009 and June 16, 2009. Only pills from lot number 311756 are affected by today’s recall.

Consumers who have pills from the recalled lot in their possession are instructed not to use the drugs and return them to their pharmacy. Wholesale and retail outlets are advised to stop distribution of the products and examine their current inventory to weed out any recalled products.

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