FDA Places Injunction Against Drug Manufacturer

The U. S. Food and Drug Administration has announced today, the U.S. District Court for the Southern District has now put in place a permanent injunction against Deltex Pharmaceuticals of Rosenberg, Texas along with its president Kabri Ahmed and vice president, Mohidur R. Khan.

This injunction puts a permanent stop for the company, along with the president and vice president from the activities of manufacturing and distributing drug products up until the time in which the company manufacturing operations and products comply with the federal law and consent decree.

Deltex Pharmaceuticals is a contract manufacturer and distributor of both prescription and over-the-counter(OTC) drugs. The compliment in which was filed by the U.S. of Justice contains detailed violations of the Federal Food, Drug and Cosmetic Act, involving the manufacturing and distributing, unapproved, adulterated and misbranded drugs. Specifically, was the fact that Deltex did not obtain the required FDA approval for its prescription drug products and failure to comply with FDA regulations that govern OTC drug products with current good manufacturing requirements(cGMP).

Dara A. Corrigan, FDA's associate commissioner for regulatory affairs, states that this injunction by the FDA shows that they definitely will petition enforcement action against those companies that are recognized as being in violation of the FDA manufacturing and drug approval requirements.

In October 31, 2008, the FDA had issued a warning letter to Deltex. This company has a history of major violations of the cGMP regulations. Inspections conducted by the FDA had numerous times discovered evidence that Deltex had manufactured and distributed unapproved, adulterated and misbranded drugs.

Since the time of issuance of the warning letter from the FDA, the company had still continued to manufacture and distribute unapproved new drugs and failed to comply with cGMP regulations.

Currently, under this consent decree, Deltex, cannot continue to manufacture and distribute any drug until at which time the company is in compliance with cGMP regulations. Also, the company cannot continue to manufacture and distribute any drug until it is FDA approved or it is in compliance with the OTC drug monographs, the regulatory mechanism for legally numerous non-prescription OTC drugs.

It was also ordered that Deltex is required to recall all drugs that were manufactured and distributed since the issuance of the warning letter, October 31, 2008, from their customers and must destroy the recalled drugs. Deltex is also required to alert their customers to the recall products at the retail level.

The consent decree also specifically states that the defendants to penalties in the amount of $2,500 per day if they fail to comply with any of the provisions of the consent decree and an additional $500 for each violation.

Some the drugs involved are as follows:

Bromphenex DM (OTC)

EndaCof-AC Syrup (Rx only)

EndaCof-C Liquid (Rx only)

EndaCof-DC Liquid (Rx only)

ExeClear-C Syrup (Rx only)

Myci-GC (OTC)

Z-Tuss AC (Rx only)

On the Deltex Pharmaceutical, Inc. website they state their dedication to quality medications, highest quality products for patients, consumers and health care partners. Sources:

Courthouse News

Deltex Pharmaceuticals

FDA