The short version
20 companies supply this market — deep enough that no single failure threatens the supply. 4 Class II recalls hit this product in the past year (Fresenius Kabi USA, LLC). One of its named manufacturing plants, Fresenius Medical Care North America, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Historically, drugs in this position went on to a new shortage within 90 days about 1.5% of the time — roughly 10× the typical drug (0.1%).
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