Fifteen Texas patients got infections after receiving calcium gluconate injections, in the latest nationwide recall associated with compounding pharmacies.
The Food and Drug Administration has announced a voluntary nationwide recall of all sterile products from a Texas compounding pharmacy, the latest in a series of recalls since last year's outbreak of fungal meningitis.
Fifteen patients at two Texas hospitals have developed bacterial bloodstream infections after receiving injections from Specialty Compounding from Cedar Park, Texas, the FDA said Sunday.
The patients had received infusions of a mineral supplement called calcium gluconate injections. It can be used as part of treatment for cardiac arrest, to treat calcium deficiency, or to treat very high potassium levels.
The patients developed bacterial bloodstream infections caused by an organism called Rhodococcus equi.
The FDA has stepped up inspections since last September's outbreak of fungal meningitis, caused by steroid injections from the New England Compounding Center in Massachusetts. Those injections caused a nationwide outbreak, which killed 63 people and sickened 749, with conditions ranging from abscesses to meningitis, a brain inflammation, according to the Centers for Disease Control and Prevention.
Compounding pharmacies have come under increased scrutiny since that outbreak. Although compounders traditionally made small amounts of drug for individual patients, many compounding pharmacies today function more like major manufacturers, shipping thousands of products at a time.
"I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder," said Sen. Tom Harkin, D-Iowa, in a statement. "The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs. I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans."
The legislation would improve the safety of compounded drugs, Harkin said, by clarifying how much oversight authority is held by state and federal authorities. The bill would also protect the nation's drug supply chain, he said, by establishing a uniform, national prescription drug-tracing framework. The bill was approved by a Senate committee in May and is now pending consideration by the full Senate.
Recent recalls include:
• Earlier this month, Illinois-based Nexus Pharmaceuticals voluntarily recalled two lots of another injectable drug, benztropine mesylate, used in the treatment of Parkinson's disease. The recall occurred after visible particles were discovered in the injections.
• In July, Beacon Hill Medical Pharmacy of Michigan recalled certain products after questions were raised about their sterility.
• In June, Illinois-based Fresenius Kabi USA recalled four lots of benztropine mesylate Injection due to the potential presence of glass particles in the vials.
No illnesses were linked to these three recalls.