View Full Version : FDA notice: voluntary recall of Dextroamphetamine


Manoa
10-15-08, 08:38 PM
http://www.fda.gov/oc/po/firmrecalls/ethex10_08.html (http://www.fda.gov/oc/po/firmrecalls/ethex10_08.html)

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) (http://www.fda.gov/oc/po/firmrecalls/ethex10_08.html)
Wed, 15 Oct 2008 14:19:00 -0500

<!--RSS_SECTION-->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.

The ADHD Fan
10-18-08, 01:23 AM
Fortunately, it appears the manufacturers noticed their mistake and took a proactive approach and followed up with the necessary precautions.

This leads to an important question though:

How accurate are the doses in some of these medications?

I'm almost afraid to find out. It has been well-documented that individuals often exhibit noticeable differences in their responses to generic vs. brand-name ADHD medications. How much of that may be attributed to discepancies in different dosing measurements among different brands. I'd be willing to bet that some manufacturers consistently come up "low" for reported doses, while others may consistently fall on the high side.

Inaccurate dosing effects are usually magnified for smaller doses (because of the greater percent error differences) on more potent medications (such as dextroamphetamine). Does anyone know how rigorous the process is for sampling and testing dosing amounts?

With the great importance of titrating and ramping and the overall sensitivity to dosing ranges (especially when starting a new medication), I really wonder how big of an effect dosing discrepancies really plays into our responses to ADHD medications? Any thoughts?