10 Class I recalls
With 10 Class 1 recalls between 2013 and 2015, Baxter ($BAX) followed up behind Hospira ($HSP) and landed in the second spot of top drug recallers, while doing so contributing to U.S. saline shortages.
Among its 10 voluntary recalls, Baxter recalled IV solutions twice, sodium chloride injections twice, peritoneal dialysis solution twice, highly concentrated potassium chloride injection once and potassium chloride once.
In January 2014, the FDA warned of a saline shortage and announced that it would work with Baxter, Hospira and Braun to boost production, warning that "product supply remains tight." Baxter, in turn, placed non-contract buyers on an allocation system and said it would elevate production levels while working to provide demand predictability for its plants. Last month, the company received U.S. approval for saline made in its Sabinanigo, Spain, plant, giving the company "greater flexibility to respond to market demand fluctuations and will help as we continue to meet patient and healthcare provider needs for this critical product," Baxter spokesperson John O'Malley said.
Manufacturing problems and other issues led to the recalls, including several instances of particulate found in solution. In one instance, a customer found four single particles in a container; an analysis showed that they were polyester fiber, nylon fiber, cotton fiber and nitrocellulose fiber.
In 2013, the FDA issued warning letters for Baxter's plants in Jayuya, Puerto Rico, and Marion, NC. The agency said it was displeased with the company for not treating mold problems at the North Carolina plant that led to it stopping production on a large-volume parenteral line.
-- Eric Sagonowsky (email | Twitter)
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