FDA (Drugs) recall action 66099
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the 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.
JCB Labs LLC is recalling 1,056 vials of Sodium Thiosulfate 25% injection because laboratory results indicate microbial contamination and sterility cannot be assured.
JCB Labs LLC is recalling 903 vials of Acetylcysteine 20% Solution because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.
JCB Labs LLC is recalling 397 vials of Sodium Citrate 4% with Gentamicin due to potential microbial contamination and unreliable sterility test results.
JCB Labs LLC is recalling 1,243 epinephrine syringes because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.
JCB Labs LLC is recalling 677 vials of Sodium Citrate 4% Solution for Injection because laboratory results indicate microbial contamination and sterility cannot be assured.