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Teva Pharmaceuticals USA

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
201812
20196
202022
202153
20227
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FDA Recall Terminated Historical recordClass II

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

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Published
July 14, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
May 26, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
May 26, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
May 26, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
May 26, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Leucovorin 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.)

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
May 26, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

by Teva Pharmaceuticals USA

Reason
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)

by Teva Pharmaceuticals USA

Reason
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Published
March 3, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Published
March 3, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Published
March 3, 2021
Distribution
Nationwide

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This page lists recalls that name Teva Pharmaceuticals USA as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.