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.
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.
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.
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.
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
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.