sodium_chloride

Baxter recalls saline after mould contamination

pharmafile | October 6, 2015 | News story | Manufacturing and Production baxter 

Following a number of recalls earlier this year, Baxter has recalled potentially a further 140,000 bags of sodium chloride due to the possibility that some bags may have mould present in them.

According to the most recent FDA Enforcement Report, the Deerfield-based 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 mould on the interior surface of an overpouch.

The product was made at a Baxter plant in Jayuya, Puerto Rico, which received an FDA warning letter two years ago for a number of problems including 20 non-conformance reports on liquid products containing everything from skin to human hair to rayon.

For as many as three years, the US has been fighting the shortages of saline, a sterile solution of sodium chloride: one of the most frequently used products in hospitals.

In order to help increase the supply chain of saline, the US allowed the import of product from plants in Europe which were not previously approved for US 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.

Although production has been redirected, recurrent recalls by Baxter and Hospira has held back the US supply chain from becoming fully replenished.

This year, Baxter has had a number of recalls of saline amounting to hundreds of thousands of bags. One recall of three lots accounted for 600,000 bags of product alone in April. They also recalled two lots in July due to contamination that turned out to be insects. Hospira also had to recall saline earlier this year after a human hair was discovered in a container.

Yasmita Kumar

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