FDA (Drugs) recall action 98496
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
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.
New Life Pharma is recalling one lot of Tirzepatide Injection 15 mg x 4 sterile multi-dose vials for lack of assurance of sterility.
New Life Pharma is recalling one lot of Tirzepatide Injection 10 mg sterile multi-dose vials for lack of assurance of sterility.
New Life Pharma is recalling one lot of Semaglutide Injection 2 mg sterile multi-dose vials for lack of assurance of sterility.
New Life Pharma is recalling two lots of Semaglutide Injection 2 mg x 10 sterile multi-dose vials for lack of assurance of sterility.