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Avkare Incorporated

Avkare Incorporated Recalls

All product recalls associated with Avkare Incorporated.

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Recall Summary

Total Recalls

5

Past Year

0

Class I (Serious)

0

Most Recent

Jul 2018

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 1–5 of 5 recalls

Valsartan Hydrochlorothiazide 320mg (Avkare) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018Nationwide• Avkare Incorporated

Valsartan Hydrochlorothiazide 320/25mg (Avkare) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018Nationwide• Avkare Incorporated

Valsartan Hydrochlorothiazide 80mg (Avkare) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Moderate

FDAJul 18, 2018Nationwide• Avkare Incorporated

Valsartan Hydrochlorothiazide 160mg (Avkare) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018Nationwide• Avkare Incorporated

Valsartan Hydrochlorothiazide 160/25mg (Avkare) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018Nationwide• Avkare Incorporated