FDA Shuts Down Deltex Pharmaceuticals
Posted By The Carlson Law Firm || 12-Oct-2012
The Food and Drug Administration (FDA) entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc. a Fort Bend County drug maker, based on “a history of significant violations,” including manufacturing and distributing unapproved, adulterated and misbranded drugs.
The FDA originally requested a permanent injunction against Deltex and its president, Kabir Ahmed, and vice president, Mohidur R. Khan, because the company allegedly failed to obtain approval for its prescription drugs, failed to comply with federal regulations governing over-the-counter drugs and did not adhere to good manufacturing practices. It conducted a number of inspections in 2008 where it found numerous violations regarding quality control procedures and laboratory testing. The FDA alleged that it made several recommendations to correct these problems, but they were not followed.
Conversely, Ahmed issued a statement, stating that “Deltex has and will continue to take all the necessary steps to comport with (manufacturing) requirements and pass FDA inspection. In addition, Deltex has for some time discontinued manufacture and distribution of those drugs which the FDA has deemed unapproved new drugs.”
As part of the consent decree, Deltex will also recall and destroy all drugs produced and distributed since Oct. 31, 2008, and inform customers of the recall. The warning will cover all the unapproved drugs intended for treating cold, flu, allergies and coughs, including Tannate Pediatric Suspension, DuohistTM DH Liquid, Ed-A-Hist DM and Bromphenex DM.
Recourse for Consumers
Consumers harmed by dangerous drugs can take action against manufacturers and retailers through a product liability action. A specific type of negligence, called strict liability, applies in these circumstances, based on an absolute duty for a manufacturer to make a product safe for the public. Otherwise, it would be particularly difficult (and expensive) for consumers to prove how the negligence occurred and make the causal link to their specific injury.
Under strict liability, a consumer is entitled to compensation if he or she is injured by a product that had an “unusually dangerous defect” (either through design, manufacture or handling). A consumer need only prove that he or she used the product in the way it was intended to be used, and there was no substantial change in the product from how it was originally sold. Using the Deltex products as an example, a consumer harmed by one of the recalled medicines could bring a claim based on the FDA violations cited in creating the drugs.
If you or a loved one has been sickened or injured by a defective drug, contact an experienced personal injury attorney to learn about your rights and options.
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