FDA: Infections prompt recall of all Specialty Compounding's sterile meds

More suspect drugs from a compounding pharmacy: The FDA says Specialty Compounding is yanking all of its sterile products after 15 patients at two Texas hospitals contracted bacterial bloodstream infections.

The patients had received calcium gluconate injections made by Specialty Compounding, based in Cedar Park, TX, the agency said. Now, officials consider all of the company's sterile drugs dispensed since May 9 to be suspect. Healthcare providers should quarantine them and return them to the company, the agency said.

"The FDA believes that use of these products would create an unacceptable risk for patients," Center for Drug Evaluation and Research Director Janet Woodcock said in a statement. "Giving a patient a contaminated injectable drug could result in a life-threatening infection."

The agency has stepped up oversight of compounding pharmacies since a fatal meningitis outbreak last year. The outbreak exposed a patchwork of state regulations covering compounding pharmacies, which originally made up drugs on an individual basis. Some compounders have expanded nationwide and function more like drug manufacturers than pharmacies. The FDA has stepped up inspections, while legislation to improve the pharmacies' oversight is pending in Congress.

Specialty Compounding said the recalled products had been shipped only to customers within Texas. "There is a potential association between the infections" and the company's calcium gluconate product, the company said in a statement. "We are voluntarily recalling all sterile products out of an abundance of caution," the company said.

The latest recall follows another just last week, affecting 45 products made by Beacon Hill Medical Pharmacy at a facility in Southfield, MI. As the worries about compounded drugs spread, some pharma companies have benefited. KV Pharmaceutical, whose Makena product's key rival is a compounded drug, has seen sales increase on fears of contaminated versions.

- see the FDA release
- read the company statement

Editor's note: This story has been updated to reflect the recalled product's distribution within Texas only, not to other states.

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