ETHEX Faces Another Recall Over Manufacturing Practices

Washington, DCA manufacturer with a prior incident for distributing products outside the bounds of good manufacturing practices is having to face the music again: More prescription prenatal and iron supplements made by ETHEX Corporation have been recalled over fear of ETHEX side effects and other concerns. In the past, ETHEX drug overdose has been an issue, although it is not clear what impact these products would have on consumers.

Earlier in the week the US Food and Drug Administration (FDA) issued a statement advising of the voluntary recall by ETHEX Corporation, which is a subsidiary of KV Pharmaceutical Company. The recall was identified as being at the wholesale level, and the FDA made a point of stressing that consumers prescribed, and currently using any of the products listed below would be ill-advised to stop taking them without consulting their family doctor, or prescribing physician.

The FDA statement of recall made reference to products that "may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP)," without identifying specifically what the cGMP failure might have been, according to the FDA.

However, ETHEX Corporation has been at the center of prior recalls for tablets that were oversized, and therefore contained as much as twice the recommended dose. The prior recall dealt with medications that were far stronger than those caught up in the current recall, and there was a concern at that time over ETHEX drug overdose, and in serious cases even a risk of death.

This latest recall, which involves products not nearly as potent as those indentified in prior recalls, is nonetheless potentially serious due to that possibility—and the problem could be the same. In a release dated January 26th and distributed 8 days prior to the FDA statement, KV Pharmaceutical referenced the fact that some of the products recalled as of January 26th have had specific lots recalled earlier due to defects found, including oversized tablets delivering dosages higher than those identified on the label.

Given the prior difficulty, this recall was initiated in an attempt to ensure that no other defective products remained on the market.

The notice of voluntary recall for the products noted below came on the same day that KV Pharmaceutical received word that the FDA would not approve a pending New Drug Application (NDA) for Gestiva, the trademarked name for alpha hydroxyprogesterone caproate.

The foregoing likely throws a wrench in KV's plans, as the drug maker had entered into a purchase agreement to acquire US and worldwide rights to Gestiva upon approval of the pending NDA. The latter was filed by an applicant other than KV Pharmaceutical, and approval had been expected by January 25th. KV thus would have expected to be in a position to generate revenues for the remainder of this fiscal year. Now, that's not going to happen. KV Pharmaceutical's fiscal year ends March 31st, 2009.

The impact on shareholder profit and revenue guidance notwithstanding, the voluntary recall not only lobs a further blow to the fortunes of the company, but also raises yet again questions about the manufacturing practices, and oversight of the nation's pharmaceutical supply.

While it was not revealed where the recalled products were manufactured, the recall serves to add heat to the already boiling concern over how tablets designed to be one size, can potentially wind up to be twice as large, and twice as potent. In some cases, twice as lethal.

Consumers should not have to question the quality of drugs, and other medications that could potentially harm them. That potential needs to be tightly monitored and controlled, and a continuation of such recalls is an indication that there is still much that is wrong with the system.

If your health, or that of a loved one has been adversely affected from ETHEX side effects from products made by ETHEX Corporation—or worse, from an ETHEX drug overdose—you would be well advised to consult a legal professional to explore your options.

Recalled Prescription Prenatal Vitamin Products
Advanced NatalCare Tablets
Advanced-RF NatalCare Tablets
Cal-Nate Tablets
CareNatal DHA Tablets
ComBgen Tablets
ComBiRxTablets
NataCaps Capsules
NatalCare Gloss Tablets
NatalCare PIC Tablets
NatalCare PIC Forte Tablets
NatalCare Plus Tablets
NatalCare Rx Tablets
NatalCare Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate Chewable Tablets
NutriSpire Tablets
Prenatal MR 90 FE Tablets
Prenatal MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets


Recalled Prescription Iron Supplement Products
Anemagen Caplets
Anemagen Forte Caplets
Conison Capsules
Fe-Tinic 150 Forte Capsules