FDA (Drugs) recall action 97368
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.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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.
Lactated Ringer's Injection USP in 1000 mL Excel containers is being recalled for lack of assurance of sterility because of the potential for fluid leakage at one of the weld sites. 74,088 containers affected.
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.