A loose hair has contributed to the nationwide shortage of saline solution, as Hospira ($HSP) recalls another lot of the commonly used product.
The drugmaker reported on Friday that it was recalling one lot of 0.9% sodium chloride injection in bags after a customer reported particulate in a single unit. Hospira said it identified the particulate as a human hair, sealed in the bag at the additive port area. The company is investigating the cause so it can take whatever steps are needed to prevent a repeat of the problem.
Hospira has been here before. This the second time in recent months that a single human hair has caused the Lake Forest, IL-based company to undertake the cost of recalling product. In September, Hospira recalled a lot of the anticoagulant heparin sodium in 0.9% sodium chloride injection when a hair was found sealed between the tube and the film at the round seal of the unused administrative port on the nonprint side of the container.
The drugmaker said on Friday that in the unlikely event a piece of the hair made it into a patient, there was a risk of an inflammatory or allergic reaction. Probably the larger concern is the effect on availability. There has been a nationwide shortage of the product for more than a year, leaving the U.S. healthcare system to rethink the use of a product that it would traditionally turn to millions of times a week.
Hospira, Baxter International ($BAX), B. Braun Medical and Fresenius Kabi and Fresenius Healthcare are all currently reporting shortages of the product. This is Hospira's second recall of saline in recent months and in August, Baxter recalled a lot.
The FDA has been working with all of those producers to boost production. It has also allowed product to be imported from two European plants that were not approved to ship saline to the U.S., a Fresenius Kabi plant in Norway and a Baxter plant in Spain.
- here's the recall notice