Recall Enforment Report D-0741-2021

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 07-29-2021 for the product 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 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0741-202107-29-202108-25-2021Class II25,653 vialsMetoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01Lack of Assurance of SterilityOngoing
D-0739-202107-29-202108-25-2021Class II34,100 vialsNorepinephrine 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 0703-1153-01Lack of Assurance of SterilityOngoing
D-0748-202107-29-202108-25-2021Class II20,800 vialsAdenosine 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 16714-180-01Lack of Assurance of SterilityOngoing
D-0743-202107-29-202108-25-2021Class II50,713 vialsMethylprednisolone 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 SterilityOngoing
D-0745-202107-29-202108-25-2021Class II6,184 vialsOctreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01Lack of Assurance of SterilityOngoing
D-0732-202107-29-202108-25-2021Class II16,226 vialsHaloperidol 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 SterilityOngoing
D-0738-202107-29-202108-25-2021Class II12,698 vialsEpoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01Lack of Assurance of SterilityOngoing
D-0735-202107-29-202108-25-2021Class II62,358 vialsVecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01Lack of Assurance of SterilityOngoing
D-0730-202107-29-202108-25-2021Class II1,351 vialsDAUNOrubicin 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 # 0703-5233-13Lack of Assurance of SterilityOngoing
D-0747-202107-29-202108-25-2021Class II42,046 vialsLeucovorin 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 0703-5145-91Lack of Assurance of SterilityOngoing
D-0744-202107-29-202108-25-2021Class II3,067 vialsOctreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01Lack of Assurance of SterilityOngoing
D-0733-202107-29-202108-25-2021Class II4,712 vialsAmikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01Lack of Assurance of SterilityOngoing
D-0740-202107-29-202108-25-2021Class II4,249 vialsAdenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01Lack of Assurance of SterilityOngoing
D-0736-202107-29-202108-25-2021Class II16,644 vialsOctreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01Lack of Assurance of SterilityOngoing
D-0742-202107-29-202108-25-2021Class II2,199 vialsAlprostadil 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 0703-1501-01Lack of Assurance of SterilityOngoing
D-0731-202107-29-202108-25-2021Class II193,845 vialsMethylprednisolone 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 SterilityOngoing
D-0737-202107-29-202108-25-2021Class II434,229 vialsLeucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01Lack of Assurance of SterilityOngoing
D-0746-202107-29-202108-25-2021Class II476,275 vialsLeucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01Lack of Assurance of SterilityOngoing
D-0734-202107-29-202108-25-2021Class II2,091 vialsIdarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11Lack of Assurance of SterilityOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0703-4502Metoclopramide MetoclopramideInjection, SolutionIntramuscular; IntravenousTeva Parenteral Medicines, Inc.Human Prescription Drug