FDA (Drugs) recall action 88442
The FDA (Drugs) publishes a recall like this one as 19 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 19 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.
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.
Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.
Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.
Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.