Texas Compounder Rebuffs FDA’s Request to Recall Potentially Contaminated Drugs

A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court.

The latest wrangling stems from a June to July inspection of Downing Labs’ Dallas facility in which investigators discovered the compounder had produced 19 lots from June 2013 to May 2014 that tested positive for microbial contamination and three lots that failed endotoxin testing.

Downing noted July 24 that it never distributed the affected lots.

But the agency said that given the rate of contamination at the facility, there is a high probability other lots in distribution could be contaminated; hence the need for the recall. The FDA’s letter requesting the recall comes nearly two months after the agency warned consumers and physicians to stay away from drugs compounded at the facility.

Downing rejected the FDA’s request to recall all of its sterile products, co-owner Ashley Downing said. Since Downing refused the request, the agency could seek a court order to have the products seized, according to federal regulations.

The agency has no authority to require that a company recall pharmaceuticals and usually only issues specific requests if the situation is urgent.

The agency has had compounders under the microscope since the 2012 deadly outbreak of fungal meningitis that resulted from tainted steroid injections made by the New England Compounding Center.

In its June/July inspection of Downing, investigators found numerous quality problems including vials from at least 184 different lots of sterile drugs that were cloudy or contained fibers or particles. Yet the company released the lots for distribution after attempting to cull the “bad vials” based on an inadequate visual inspection, the FDA noted.

Furthermore, the company’s investigations into the 22 lots that failed quality testing were poor, the agency said. Downing pinned the failures on poor aseptic techniques by the operator and high endotoxin levels in the active pharmaceutical ingredients, but didn’t support the theory with any data, the FDA noted.

Downing said July 24 on its website that it had made numerous quality improvements to its facility, including hiring an FDA-approved, third-party lab to perform all sterility and endotoxin testing. The company also asserted that the FDA inspected the facility per drug manufacturing quality standards, rather than the less stringent United States Pharmacopeia standards that govern state-regulated compounding pharmacies.

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