FDA daily for Saturday, October 17, 2026
In this issue: 1 approval, 2 device recalls and 2 label changes.
Drug and biologic approvals
FDA date:On Sat, Oct 10 FDA approved no new applications and 1 supplement to existing ones.
- ATNAA
US ARMY · ATROPINE, PRALIDOXIME CHLORIDE
Device recalls
FDA date:FDA posted 2 device recalls from 1 firm on Sat, Oct 10.
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Instrumentation Laboratory · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Label updates
FDA date:2 drug labels took effect on Sat, Oct 3.
Browse label updates in FDA data →FDA did not answer for Clearances, Drug shortages, Drug recalls, Food and supplement recalls while this issue was written; those sections will fill in on a later visit.
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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