D-0741-2021 | 07-29-2021 | 08-25-2021 | Class II | 25,653 vials | Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01 | Lack of Assurance of Sterility | Ongoing |
D-0739-2021 | 07-29-2021 | 08-25-2021 | Class II | 34,100 vials | Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01 | Lack of Assurance of Sterility | Ongoing |
D-0748-2021 | 07-29-2021 | 08-25-2021 | Class II | 20,800 vials | Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01 | Lack of Assurance of Sterility | Ongoing |
D-0743-2021 | 07-29-2021 | 08-25-2021 | Class II | 50,713 vials | Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Lack of Assurance of Sterility | Ongoing |
D-0745-2021 | 07-29-2021 | 08-25-2021 | Class II | 6,184 vials | Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01 | Lack of Assurance of Sterility | Ongoing |
D-0732-2021 | 07-29-2021 | 08-25-2021 | Class II | 16,226 vials | Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. | Lack of Assurance of Sterility | Ongoing |
D-0738-2021 | 07-29-2021 | 08-25-2021 | Class II | 12,698 vials | Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01 | Lack of Assurance of Sterility | Ongoing |
D-0735-2021 | 07-29-2021 | 08-25-2021 | Class II | 62,358 vials | Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01 | Lack of Assurance of Sterility | Ongoing |
D-0730-2021 | 07-29-2021 | 08-25-2021 | Class II | 1,351 vials | DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13 | Lack of Assurance of Sterility | Ongoing |
D-0747-2021 | 07-29-2021 | 08-25-2021 | Class II | 42,046 vials | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91 | Lack of Assurance of Sterility | Ongoing |
D-0744-2021 | 07-29-2021 | 08-25-2021 | Class II | 3,067 vials | Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01 | Lack of Assurance of Sterility | Ongoing |
D-0733-2021 | 07-29-2021 | 08-25-2021 | Class II | 4,712 vials | Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01 | Lack of Assurance of Sterility | Ongoing |
D-0740-2021 | 07-29-2021 | 08-25-2021 | Class II | 4,249 vials | Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01 | Lack of Assurance of Sterility | Ongoing |
D-0736-2021 | 07-29-2021 | 08-25-2021 | Class II | 16,644 vials | Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01 | Lack of Assurance of Sterility | Ongoing |
D-0742-2021 | 07-29-2021 | 08-25-2021 | Class II | 2,199 vials | Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01 | Lack of Assurance of Sterility | Ongoing |
D-0731-2021 | 07-29-2021 | 08-25-2021 | Class II | 193,845 vials | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Lack of Assurance of Sterility | Ongoing |
D-0737-2021 | 07-29-2021 | 08-25-2021 | Class II | 434,229 vials | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01 | Lack of Assurance of Sterility | Ongoing |
D-0746-2021 | 07-29-2021 | 08-25-2021 | Class II | 476,275 vials | Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01 | Lack of Assurance of Sterility | Ongoing |
D-0734-2021 | 07-29-2021 | 08-25-2021 | Class II | 2,091 vials | Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11 | Lack of Assurance of Sterility | Ongoing |