The FDA and Barr Laboratories, Inc. have announced a recall for generic Adderall tablets that may contain more of the active pharmaceutical ingredients than they are supposed to have, posing a risk of serious side effects among users of the ADHD drug.
The generic drug recall was issued on August 14 for one lot of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (mixed amphetamine salts) 20 mg tablets, which were sold in 100 count bottles. Some of the tablets from lot 311756 could contain tablets exceed weight requirements, which may result in super-potent pills.
The generic Adderall tablets are approved to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, and are also often used off-label for weight loss. The 20mg pills are oval and peach in color, with “b/973″ stamped on one side and “2/0” stamped on the other. The recalled Barr ADHD pills were distributed between June 11, 2009 and June 16, 2009, but could have been filled by a pharmacy after that.
Taking an oversized pill could lead to an overdose, with symptoms like 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.
No injuries have been reported in connection with the oversized tablets, according to Barr Laboratories. Consumers who have any of the recalled dextroamphetamine/amphetamine tablets have been advised to stop using the drug and contact their doctor or pharmacist. Any adverse reactions should be reported to the FDA’s MedWatch program.
The recall is the latest in a string of recalls involving generic drugs that were distributed with too much of the active medication in each tablet.
In late June 2009, U.S. Marshals raided generic drug manufacturer Caraco Pharmaceutical Laboratories, Ltd., shutting down production due to unsafe manufacturing processes that allowed similar problems to occur. In March, Caraco issued a generic digoxin recall for tablets of their heart medication due to irregular sized pills.
In April 2008, a Digitek recall was issued by Actavis Totowa for their brand of digoxin which were distributed with up to twice the appropriate amount of the active pharmaceutical ingredient. At least 667 deaths from digoxin overdose were linked to the recalled Digitek tablets in FDA adverse event reports following the announcement of the manufacturing problems.
Last year, generic drug maker Ethex Corp suspended manufacturing and shipments for all products after issuing several generic drug recalls due to oversized tablets. Among tablets that were distributed with too much of the active medication were generic versions of morphine, which could cause a potentially fatal morphine overdose. Also included in the recall were dextroamphetamine tablets that were generic versions of Dexedrine and Dextrostate.