| Jan 18, 2022 |
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... |
Failed Dissolution Specification: Dissolution results are below specification... |
Class II |
| Jan 10, 2022 |
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... |
Failed Dissolution Specifications; Low Out of specification (OOS) results for... |
Class II |
| Jan 7, 2022 |
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... |
Mislabeling |
Class III |
| Jan 7, 2022 |
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... |
Mislabeling |
Class III |
| Dec 31, 2021 |
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose... |
Lack of Assurance of Sterility |
Class II |
| Dec 31, 2021 |
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... |
Lack of Assurance of Sterility |
Class II |
| Dec 16, 2021 |
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) ... |
Subpotent |
Class II |
| Dec 8, 2021 |
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottl... |
Defective Container: The notch in the cap that fits into the nozzle of the dr... |
Class II |
| Oct 28, 2021 |
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... |
Failed Impurities/Degradation Specifications |
Class III |
| Oct 27, 2021 |
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx... |
Labelling: Incorrect Exp. Date |
Class II |
| Sep 22, 2021 |
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... |
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol |
Class II |
| Sep 22, 2021 |
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... |
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol |
Class II |
| Sep 22, 2021 |
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... |
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol |
Class II |
| Sep 22, 2021 |
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... |
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol |
Class II |
| Sep 22, 2021 |
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) ... |
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol |
Class II |
| Jul 29, 2021 |
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceutic... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx on... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx on... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... |
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Mic... |
Class II |
| Jul 29, 2021 |
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vi... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva ... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Tev... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... |
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Mic... |
Class II |
| Jul 29, 2021 |
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... |
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Mic... |
Class II |
| Jul 29, 2021 |
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, p... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in ... |
Lack of Assurance of Sterility |
Class II |
| Jul 29, 2021 |
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Ph... |
Lack of Assurance of Sterility |
Class II |
| Jun 18, 2021 |
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... |
Presence of Particulate Matter: Complaint received of a glass particle observ... |
Class I |
| Apr 26, 2021 |
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... |
Lack of Assurance of Sterility |
Class II |
| Apr 26, 2021 |
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... |
Lack of Assurance of Sterility |
Class II |
| Apr 26, 2021 |
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... |
Lack of Assurance of Sterility |
Class II |
| Apr 26, 2021 |
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... |
Lack of Assurance of Sterility |
Class II |
| Apr 26, 2021 |
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... |
Lack of Assurance of Sterility |
Class II |
| Mar 4, 2021 |
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... |
Failed Impurity/Degradation Specifications: Out-of-specifications results obs... |
Class III |
| Feb 15, 2021 |
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials,... |
Chemical contamination; Unknown brown residue adhering to the inside of one v... |
Class II |
| Feb 10, 2021 |
MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ... |
Lack of Assurance of Sterility: manufacturing areas for the recalled products... |
Class II |
| Feb 10, 2021 |
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only... |
Lack of Assurance of Sterility: manufacturing areas for the recalled products... |
Class II |
| Feb 10, 2021 |
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... |
Lack of Assurance of Sterility: manufacturing areas for the recalled products... |
Class II |
| Feb 10, 2021 |
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... |
Lack of Assurance of Sterility: manufacturing areas for the recalled products... |
Class II |
| Feb 10, 2021 |
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... |
Lack of Assurance of Sterility: manufacturing areas for the recalled products... |
Class II |