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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

Past Year

Class I (Serious)

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 41–45 of 45 recalls

buPROPion HCl Extended-Release Tablets (Wockhardt) – Impurity Concerns (2014)

Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.

Class IIILow

FDAJul 14, 2014Nationwide• Wockhardt Usa Inc.

Metoprolol Succinate Tablets (Wockhardt) – failed dissolution (2014)

Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Class IIILow

FDAApr 17, 2014Nationwide• Wockhardt Usa Inc.

Metoprolol Succinate Tablets (Wockhardt) – dissolution failure (2014)

Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

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Class II

Moderate

FDAApr 10, 2014Nationwide• Wockhardt Usa Inc.

Metoprolol Succinate Tablets (Wockhardt) – dissolution failure (2014)

Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

Class IIModerate

FDAApr 1, 2014Nationwide• Wockhardt Usa Inc.

Pantaprazole Sodium Tablets (Wockhardt) – Dissolution Failure (2013)

Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.

Class IIModerate

FDANov 27, 2013Nationwide• Wockhardt Usa Inc.