More Trouble for Ethex Corporation, More Drugs Recalled

Rockville, MDThe troubles continue for Ethex. Just weeks after the pharmaceutical manufacturer announced a recall of five generic drugs having the potential to be oversized, yet another generic drug in its roster has been put on the recall block for the exact same reason.

Just before Christmas, Ethex Corporation triggered a voluntary recall of a single production lot of Hydromorphone HCI tablets as a precaution. The latter is a drug used for pain management, and the possibility of taking a higher dose could bring on symptoms including, but not limited to respiratory depression, low blood pressure and even sedation.

The single lot of 2mg tablets is stamped as Lot # 90219 and carries an expiry date of 03 / 10 (March of next year). The NDC number identified is 58177-0620-04. The Hydromorphone HCI 2 mg tablets are blue in color and round in shape with a script "E" stamped on one side, and a "2" stamped into the opposite side of the potentially oversized tablet.

Oversized tablets have been a fixture in the news with increasing frequency of late, which suggests a growing breakdown in good manufacturing practices (GMP). Last year it was the double-dose digoxin debacle, where oversized heart pills were proving to be a serious risk to heart patients.

The manufacturer involved in that issue later had to recall all of its generic products manufactured at a single production facility, for the same problem. The US Food and Drug Administration (FDA) had previously inspected the facility and had warned the manufacturer of problems with their manufacturing, and quality control practices. While the manufacturer had promised that reforms would be made, problems continued resulting in an eventual, massive recall of product.

Then in the fall, Ethex Corporation issued its own voluntary recall of five generic drugs due to the potential for oversized tablets:

Propafenone HCl Tablets - 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets – 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets - 15 mg
Morphine Sulfate Immediate Release Tablets - 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets - 10 mg

And now, this. There is no word as to the FDA's reaction to this latest recall, although the federal drug agency has been notified (as of December 19th) and would of course be keeping tabs on the situation. The manufacturer has indicated that it is keeping the FDA informed with regard to ongoing developments.

There is no word on what the FDA may be considering, given this is the second recall by Ethex Corporation in as many months, and for the same problem—the potential for oversized tablets. It could be assumed that the FDA would be looking into the manufacturing practices of the company, but that has not been stated. For now, it appears that Ethex is conducting its own investigation, and will keep the FDA informed.

There was no word on just where the potentially oversized tablets were manufactured.

It is not beyond the reasonable expectation of the consumer to assume a product is of the finest quality, especially if it is a medical drug ingested, and depended upon for maintaining good health. Further to that, the possibility that a manufacturing process could sufficiently break down to allow two, single-dose tablets to be mashed together in the manufacturing process—and therefore posing a health risk to the consumer—is beyond comprehension. Where is the inspection? Where is the quality control? Where is the failsafe?

Questions that the manufacturer, the FDA and the consumer all have to ask. The latter, if harmed in any way, may opt to have his, or her questions asked on their behalf by qualified legal counsel.