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Wockhardt Usa Inc.

Wockhardt Usa Inc. Recalls

All product recalls associated with Wockhardt Usa Inc..

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Recall Summary

Total Recalls

45

Past Year

0

Class I (Serious)

0

Most Recent

Aug 2017

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 1–20 of 45 recalls

Enalapril Maleate Tablets (Wockhardt) – Impurity Specifications (2017)

Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.

FDAAug 22, 2017Nationwide• Wockhardt Usa Inc.

Lisinopril Tablets 5mg (Wockhardt) – Manufacturing Deviation (2015)

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Class IIModerate

FDAJul 29, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril Tablets 20mg (Wockhardt) – Manufacturing Deviation (2015)

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

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Moderate

FDAJul 29, 2015Nationwide• Wockhardt Usa Inc.

Lamotrigine 25mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Amlodipine Besylate Tablets (Wockhardt) – CGMP Deviation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril 20mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Zonisamide 25mg Capsules (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Lansoprazole Capsules (Wockhardt) – quality investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Captopril 25mg Tablets (Wockhardt) – quality investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Azithromycin 500mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Famotodine 40mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Clarithromycin 500mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Azithromycin 600mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Famotodine 20mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril Tablets 30mg (Wockhardt) – CGMP Deviation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Amlodipine Besylate 10mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Metoprolol Succinate 50mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Zolpidem Tartrate 10mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril 40mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Azithromycin 250mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.