Teva North America Recalls

All product recalls associated with Teva North America.

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Recall Summary

Total Recalls

12

Past Year

0

Class I (Serious)

0

Most Recent

Aug 2016

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–12 of 12 recalls

Claravis (Teva) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAAug 5, 2016Nationwide• Teva North America

Children's Qnasl (Teva) – Content Uniformity Issue (2016)

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Class IIILow

FDAJul 15, 2016Nationwide• Teva North America

Amoxicillin Oral Suspension (Teva) – Superpotent Drug (2016)

Superpotent drug: Out of specification test result for assay during stability testing.

Class II

Moderate

FDAJun 24, 2016Nationwide• Teva North America

Albuterol Sulfate Syrup (Teva) – Foreign Substance Presence (2016)

Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

Class IIModerate

FDAJun 22, 2016Nationwide• Teva North America

Ondansetron Injection (Teva) – Manufacturing Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJun 17, 2016Nationwide• Teva North America

Argatroban Injection (Teva) – Manufacturing Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJun 17, 2016Nationwide• Teva North America

Linezolid Injection (Teva) – Manufacturing Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJun 17, 2016Nationwide• Teva North America

Eptifibatide Injection (Teva) – Manufacturing Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJun 17, 2016Nationwide• Teva North America

MitoXantrone Injection (Teva) – impurity D found (2016)

Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

Class IIILow

FDAMay 31, 2016Nationwide• Teva North America

Divalproex Sodium Tablets (Teva) – Failed Tablet Specs (2016)

Failed Tablet/Capsule Specifications

Class IIILow

FDAMay 18, 2016Nationwide• Teva North America

Linezolid Injection (Teva) – sterility assurance risk (2016)

Lack of Assurance of Sterility: Due to potential for leaking bags.

Class IIModerate

FDAApr 27, 2016Nationwide• Teva North America

Capecitabine Tablets (Teva) – Dissolution Failure (2015)

Failed Dissolution Specifications: low test results at the 18 month time-point

Class IIModerate

FDADec 21, 2015Nationwide• Teva North America

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Teva North America Recalls

Recall Summary

Claravis (Teva) – Impurity Specification Failure (2016)

Children's Qnasl (Teva) – Content Uniformity Issue (2016)

Amoxicillin Oral Suspension (Teva) – Superpotent Drug (2016)

Albuterol Sulfate Syrup (Teva) – Foreign Substance Presence (2016)

Ondansetron Injection (Teva) – Manufacturing Deviation (2016)

Argatroban Injection (Teva) – Manufacturing Deviation (2016)

Linezolid Injection (Teva) – Manufacturing Deviation (2016)

Eptifibatide Injection (Teva) – Manufacturing Deviation (2016)

MitoXantrone Injection (Teva) – impurity D found (2016)

Divalproex Sodium Tablets (Teva) – Failed Tablet Specs (2016)

Linezolid Injection (Teva) – sterility assurance risk (2016)

Capecitabine Tablets (Teva) – Dissolution Failure (2015)