FDA (Drugs) recall action 87298
The FDA (Drugs) publishes a recall like this one as 15 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 15 pages.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
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.
Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Toposar (etoposide) injection vials because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling specific lots of Vecuronium Bromide for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Desmopressin Acetate Injection because manufacturing areas exceeded microbial limits, compromising sterility assurance.
Teva Pharmaceuticals is recalling specific lots of Sterile Diluent for Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Metoclopramide Injection because manufacturing areas exceeded microbial acceptance levels, creating a lack of sterility assurance.
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling Dacarbazine for Injection USP because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling 15,043 vials of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Teva Pharmaceuticals is recalling 6,710 vials of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.