First It Was Their Morphine Tablets; Now ETHEX Dextroamphetamine 5mg Pills May Be Oversized And Contain Two Times The Active Ingredient

(Posted by Tom Lamb at DrugInjuryWatch.com)

By means of an October 16, 2008 MedWatch Email Alert the FDA announced that ETHEX Corporation has recalled three lots of Dextroamphetamine Sulfate 5mg tablets because of the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. From the October 16 FDA Alert:

Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

An October 15 drug company press release, "ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets — Lot Number 77946, 81141 and 81142 NDC #58177-311-04", provides these details:

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

… ETHEX Corporation is conducting this precautionary, voluntary recall because it found a small number of oversized tablets in lots which had not yet been distributed. These oversized tablets were removed before the lots were distributed.

Previously, in June 2008 ETHEX Corp. announced that it was recalling Morphine Sulfate 60 mg Extended Release Tablets.  With this earlier situation, initially there was the recall of a single lot due to a report of a tablet with twice the appropriate thickness.  Soon thereafter, however, that first ETHEX recall was expanded to all 30 mg and 60 mg Morphine Sulfate Extended Release Tablets made during a two-year period, June 2006 To May 2008.

As you may know already, in April 2008 Actavis Totowa LLC recalled all strengths of Digitek due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.  These "double-dose" Digitek pills created a risk of ditigalis toxicity, especially in patients with renal failure.  Since then, numerous personal injury and wrongful death Digitek lawsuits have been filed against Actavis.

As I have asked rhetorically in the recent past:

Where is the FDA on taking steps to ascertain that Good Manufacturing Practices (GMP) are being adhered to so that our nation's supply of FDA-approved generic drugs is safe?

What do you think about this series of double-dose pill recalls involving ETHEX and Actavis?