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Pharmaceuticals / Submissions and Approvals

IV Bag Shortage Continues After Hurricane Maria Damage, FDA Says

Nov. 22, 2017
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The FDA continues to grapple with shortages of saline intravenous injection bags that were worsened when Hurricane Maria devastated Puerto Rico, and the agency is temporarily allowing the importation of bags to boost the supply, Commissioner Scott Gottlieb said.

Shortages of the bags have been reported intermittently since 2014, but the hurricane exacerbated them significantly when it struck Puerto Rican manufacturers, he said. The FDA has been working with Baxter, owner of a storm-damaged bag factory in Puerto Rico, to restore its production.

The FDA recently has approved saline bags for import from Fresenius Kabi, a German producer, and from Grifols, headquartered in Spain, Gottlieb said.

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