FDA (Drugs) recall action 66103
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
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.
Leiter's Pharmacy is recalling 265 vials of compounded Bevacizumab (Avastin) because a testing lab reported failed sterility results as passing, making the product's sterility unassured.
Leiter's Pharmacy is recalling 728 vials of Lidocaine/Phenylephrine PF 1%/1.5% injectible solution because sterility cannot be assured after failed test results were incorrectly reported as passing.
Leiter's Pharmacy is recalling 56 vials of Dextrose 50% Injection Solution because sterility cannot be assured after testing errors were discovered.
Leiter's Pharmacy is recalling 810 vials of Hyaluron (hyaluronidase) 150 units/mL due to bacterial contamination and unverified sterility.