FDA (Drugs) recall action 79772
The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
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.
AuroMedics Pharma LLC is recalling Levetiracetam Injection due to a lack of assurance of sterility and a confirmed report of leaking bags and mold.
AuroMedics Pharma LLC is recalling 308,112 bags of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of mold.
AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.
AuroMedics Pharma LLC is recalling Linezolid Injection bags due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.
AuroMedics Pharma LLC is recalling 67,300 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.
AuroMedics Pharma LLC is recalling 261,250 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.
AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and reports of leaking bags with mold.