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Teva Pharmaceuticals USA FDA Recalls
60 recalls on file across drugs, 1 of them Class I and 0 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, ManufaClass IIJan 18, 2022Failed Dissolution Specification: Dissolution results are be |
| Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-08Class IIJan 10, 2022Failed Dissolution Specifications; Low Out of specification |
| Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, ManufClass IIIJan 7, 2022Mislabeling |
| Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, ManufaClass IIIJan 7, 2022Mislabeling |
| MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, ManufactuClass IIDec 31, 2021Lack of Assurance of Sterility |
| Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, ManufClass IIDec 31, 2021Lack of Assurance of Sterility |
| Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NClass IIDec 16, 2021Subpotent |
| Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropperClass IIDec 8, 2021Defective Container: The notch in the cap that fits into the |
| Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT IClass IIIOct 28, 2021Failed Impurities/Degradation Specifications |
| Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) ManufacClass IIOct 27, 2021Labelling: Incorrect Exp. Date |
| AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Class IISep 22, 2021Subpotent drug: OOS results of Label Claimed Emitted Dose fo |
| AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: TevaClass IISep 22, 2021Subpotent drug: OOS results of Label Claimed Emitted Dose fo |
| AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva RClass IISep 22, 2021Subpotent drug: OOS results of Label Claimed Emitted Dose fo |
| AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: TevClass IISep 22, 2021Subpotent drug: OOS results of Label Claimed Emitted Dose fo |
| AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, RClass IISep 22, 2021Subpotent drug: OOS results of Label Claimed Emitted Dose fo |
| Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), anClass IIJul 29, 2021Lack of Assurance of Sterility |
| Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis LaboratoriClass IIJul 29, 2021CGMP Deviations: Out of specification (OOS) test result for |
| Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), anClass IIJul 29, 2021Lack of Assurance of Sterility |
| Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose Class IIJul 29, 2021Lack of Assurance of Sterility |
| Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis LaboratoriClass IIJul 29, 2021CGMP Deviations: Out of specification (OOS) test result for |
| Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva PharmaceuticClass IIJul 29, 2021Lack of Assurance of Sterility |
| DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral MedicineClass IIJul 29, 2021Lack of Assurance of Sterility |
| Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. IrviClass IIJul 29, 2021Lack of Assurance of Sterility |
| Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 194Class IIJul 29, 2021Lack of Assurance of Sterility |
| Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. IrClass IIJul 29, 2021Lack of Assurance of Sterility |
| Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. NorClass IIJul 29, 2021Lack of Assurance of Sterility |
| Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine,Class IIJul 29, 2021Lack of Assurance of Sterility |
| Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North WaClass IIJul 29, 2021Lack of Assurance of Sterility |
| Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-0Class IIJul 29, 2021Lack of Assurance of Sterility |
| Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis LaboratorClass IIJul 29, 2021CGMP Deviations: Out of specification (OOS) test result for |
| Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx onClass IIJul 29, 2021Lack of Assurance of Sterility |
| Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-29Class IIJul 29, 2021Lack of Assurance of Sterility |
| Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USClass IIJul 29, 2021Lack of Assurance of Sterility |
| Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PAClass IIJul 29, 2021Lack of Assurance of Sterility |
| Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA Class IIJul 29, 2021Lack of Assurance of Sterility |
| Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 1Class IIJul 29, 2021Lack of Assurance of Sterility |
| Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC MeClass IIJul 29, 2021Lack of Assurance of Sterility |
| Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton Class IJun 18, 2021Presence of Particulate Matter: Complaint received of a glas |
| Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. IrvinClass IIApr 26, 2021Lack of Assurance of Sterility |
| Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals,Class IIApr 26, 2021Lack of Assurance of Sterility |
| Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva PharmaceuticalsClass IIApr 26, 2021Lack of Assurance of Sterility |
| Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals Class IIApr 26, 2021Lack of Assurance of Sterility |
| Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, TClass IIApr 26, 2021Lack of Assurance of Sterility |
| Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01Class IIIMar 4, 2021Failed Impurity/Degradation Specifications: Out-of-specifica |
| Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva PharmaceuticaClass IIFeb 15, 2021Chemical contamination; Unknown brown residue adhering to th |
| Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per TrayClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per traClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., NortClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva PClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0Class IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25Class IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL SingleClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in Class IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva PharClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA,Class IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva PhaClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA Class IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, Class IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., NortClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |
| Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged inClass IIFeb 10, 2021Lack of Assurance of Sterility: manufacturing areas for the |