The U.S. supply of saline is taking another hit as Baxter ($BAX) recalls yet more sodium chloride: nearly 140,000 bags more. This time the recall is because of the possibility that some of those bags have mold in them.
According to the most recent FDA Enforcement Report, the Deerfield, IL, company is recalling 139,104 bags of its 100-ml minibag Viaflex containers of 0.9% sodium chloride injection. It initiated the voluntary recall after receiving a complaint of mold on the interior surface of an overpouch.
According to the recall notice, the product was made at a Baxter plant in Jayuya, Puerto Rico. That plant received an FDA warning letter two years ago for a number of problems including 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon.
For about three years now, the U.S. has been battling shortages of saline, one of the most frequently used products in a hospital. To help replenish the nation's supply chain, it has allowed the import of product from some plants in Europe that were not previously approved for U.S. distribution. A Baxter plant in Spain was approved earlier this year, and the agency has also granted temporary permission to a Fresenius Kabi plant in Norway and a B. Braun plant in Germany.
But even as production has been redirected, repeated recalls by Baxter and Hospira have kept the U.S. supply chain from getting fully replenished. Baxter has had a number of recalls of saline this year amounting to hundreds of thousands of bags. One recall of three lots in April alone accounted for 600,000 bags of product. It recalled two lots in July because of particulate that turned out to be insects. Hospira had to recall a lot of saline earlier this year after a human hair was discovered in a container.
- here's the recall notice