With the completion of a spinoff July 1, Baxter International ($BAX) let go of most of its drug operations go with Baxalta ($BXLT) while keeping its dialysis equipment, IV pumps and solutions, and injectable drugs and intravenous nutrition. In that category falls saline solution, and Baxter is again having to recall some of that; in this case, two lots because a customer discovered particulate that turned out to be insects.
Baxter Friday issued a recall of one lot of 0.9% sodium chloride injection, in the 50 mL size of its Viaflex plastic container and one lot of the 100 mL mini-bag containers. The company said that the buggy particulate was discovered before the products were given to patients.
Baxter spokesman John O'Malley said in a statement that "Patient safety is Baxter's top priority, and we have voluntarily issued this recall to ensure that no product from the affected two lots remains in the field. The matter was identified prior to patient administration and to date there have been no adverse events associated with this recall reported to Baxter. We regret any inconvenience."
Baxter has increased production of saline at the request of the FDA, which has been working with drug manufacturers to help it try to deal with a national shortage of the common but essential treatment which has now stretched well into its second year. But even as the company has increased production, it has found itself recalling hundreds of thousands of units of for manufacturing problems that have included leaky bags as well as particulate contamination.
In April, it recalled three lots, amounting to nearly 600,000 units, in the 500 mL size of its Viaflex plastic containers. The recall came after the company received complaints that some of the containers were missing closures and leaked, leaving questions about the sterility of the product. A short time later, it recalled another 8 lots because particulate was discovered in it that it said was traced back to particulate material from a solution transmission system pump. It said that there had been no adverse reactions reported, but acknowledged that the particulate could cause reactions from an inflammation to something more serious in high-risk patients.
The FDA has been working with Baxter, Hospira ($HSP) and B. Braun Medical to boost their U.S. production to help relieve the situation. It also has allowed imports from three European plants that were not approved to ship saline to the U.S.: a Fresenius Kabi plant in Norway, a Baxter plant in Spain and a B. Braun plant in Germany. But recalls by Baxter and Hospira have kept the U.S. supply chain from getting fully replenished. Hospira had to recall a lot of saline earlier this year after a human hair was discovered in a container.
Insects have been found in sterile products before. A Fresenius APP Pharmaceuticals plant in New York received a 2012 warning letter that included complaints about insects being found in vials. The FDA in January upgraded that plant's standing to a so-called voluntary action indicated (VAI) after Fresenius made improvements there.
- here's the recall release