FDA (Drugs) recall action 97433
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Presence of Particulate Matter.
Presence of Particulate Matter
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
B. Braun 0.9% Sodium Chloride Injection USP in 1000 mL containers, lot V3K770, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 47,148 containers are affected.
B. Braun Lactated Ringer's Injection USP in 1000 mL containers, lot J4S807, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 46,032 containers are affected.