Fagron Receives FDA Warning Letter Over IV Bag-related Product Issues
15 maj, 08:15
02:15 AM EDT, 05/15/2026 (MT Newswires) -- Fagron (FAGR.BR) received a warning letter on Tuesday from the US Food and Drug Administration related to drug products produced using intravenous, or IV, bags supplied by a third-party manufacturer at its Boston, US, facility.
The warning letter follows an FDA inspection of the facility in November 2025 and also covers certain process improvements, the Belgian pharmaceutical supplier said Friday.
Fagron noted that it identified quality issues in the third-party-supplied IV bags and, in February, initiated a limited voluntary Class II recall of selected drug products, with no adverse events recorded.
The company added that corrective actions have since been implemented and that it will respond to the warning letter within the FDA's required timeframe.
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Fagron Receives FDA Warning Letter Over IV Bag-related Product Issues
15 maj, 08:15
02:15 AM EDT, 05/15/2026 (MT Newswires) -- Fagron (FAGR.BR) received a warning letter on Tuesday from the US Food and Drug Administration related to drug products produced using intravenous, or IV, bags supplied by a third-party manufacturer at its Boston, US, facility.
The warning letter follows an FDA inspection of the facility in November 2025 and also covers certain process improvements, the Belgian pharmaceutical supplier said Friday.
Fagron noted that it identified quality issues in the third-party-supplied IV bags and, in February, initiated a limited voluntary Class II recall of selected drug products, with no adverse events recorded.
The company added that corrective actions have since been implemented and that it will respond to the warning letter within the FDA's required timeframe.
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