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  3. Recall Enforcement Event ID: 87875

Recall Enforment Report D-0377-2021

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 04-26-2021 for the product Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0377-202104-26-202105-26-2021Class II3,138/25 single use vials per trayMetoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04Lack of Assurance of SterilityTerminated
D-0375-202104-26-202105-26-2021Class II3150 vialsHaloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03Lack of Assurance of SterilityTerminated
D-0378-202104-26-202105-26-2021Class II7020 vialsHaloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03Lack of Assurance of SterilityTerminated
D-0376-202104-26-202105-26-2021Class II7,564/1 multiple dose vial per cartonMethylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01Lack of Assurance of SterilityTerminated
D-0374-202104-26-202105-26-2021Class II192,277 cartons/1 single dose vial per cartonLeucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)Lack of Assurance of SterilityTerminated

Recalled Products

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