SCA Pharma set out to expand capacity for key drugs earlier this summer. Now, the compounding pharmacy is pulling one of its critical meds—common blood thinner heparin—from hospitals nationwide over inaccurate labeling and a misplaced preservative.
SCA Pharma recalled 10 lots of compounded heparin products after an incorrect preservative, benzyl alcohol, showed up in samples.
The outsourcer noticed something was awry when quality control checks showed lower-than-expected potency in the suspect lots. Further investigation confirmed the presence of benzyl alcohol, while the preservatives noted on the label, methylparaben and propylparaben, were absent.
Hospitals across the U.S. received shipments of SCA's heparin sodium, used to treat and prevent blood clots. The recall affects multiple concentrations in both 500-milliliter and 1,000-milliliter intravenous bags, SCA said. The compounder is contacting its customers by mail for return of the drug.
SCA hasn't received word of any side effects related to the recall, but unintended exposure to benzyl alcohol carries some serious health risks in children and women who are nursing or pregnant.
Premature and low-birth weight infants who receive heparin infusions in neonatal intensive care units could suffer seizures, bleeding in the skull, liver and kidney failure or other reactions if given a benzyl alcohol-preserved solution, SCA said. Those reactions may lead to death or "gasping syndrome," with the risk especially high in preterm newborns.
Benzyl alcohol is contraindicated in pregnant women for that very reason. Plus, infants can absorb the preservative through breast milk, making it a no-go for women who are nursing as well.
But heparin's uses are many and varied—so much so that the anticoagulant has found its way onto the FDA's short supply list.
German drugmaker Fresenius Kabi and Pfizer-owned Hospira both have heparin products that are either unavailable or limited. In Hospira's case, supplies are thin, but expected to recover by October. Meanwhile, Fresenius Kabi—one of the nation's biggest heparin suppliers—is fresh out of two separate concentrations, with the next availability pegged for February.
Deerfield, Illinois-based Baxter Healthcare has two heparin products in shortage, and in May 2019 began importing one of them from a U.K. manufacturing facility to build out U.S. stores.
Heparin shortages are nothing new. Back in 2018, a rash of African swine fever dealt a blow to Chinese-made crude heparin, derived from pig intestines. Congress sounded the alarm in July 2019, with six congressional leaders from both parties appealing to the FDA to shore up domestic heparin supplies.
Though heparin has run short for some time, pandemic-related supply constraints gave compounders a chance to step in. In April, the agency gave the go-ahead for hospitals to treat certain COVID-19 patients using scarce drugs sourced from compounding pharmacies. The regulation will last as long as hospitals suffer shortages of key meds, and it allows compounders that are not already FDA-sanctioned "outsourcers" to join the cause.
When that FDA ruling came down, SCA already bore the FDA's 503B "outsourcer" designation—which clears it to supply hospitals with drugs—and earlier this summer, it laid out plans for a double expansion to boost capacity.
The company said it would expand capacity at a manufacturing plant in Windsor, Connecticut, and add on to a sterile injectables facility at the Clinton International Airport in Little Rock, Arkansas, earmarking $10 million for that effort. The Arkansas upgrade is expected to double SCA's 180-strong Little Rock workforce, the company said.