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Sun Pharma Global Fze

Sun Pharma Global Fze Recalls

All product recalls associated with Sun Pharma Global Fze.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Feb 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 1–4 of 4 recalls

Alendronate Sodium Tablets (Sun Pharma) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.

Class IIModerate

FDAFeb 11, 2016Nationwide• Sun Pharma Global Fze

Bupropion Hydrochloride Tablets (Sun Pharma) – dissolution failure (2015)

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Class IIILow

FDAJul 17, 2015Nationwide• Sun Pharma Global Fze

Ketorolac Ophthalmic Solution (Sun Pharma) – Particulate Contamination (2015)

Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.

Class IIModerate

FDAJan 21, 2015Nationwide• Sun Pharma Global Fze

Levetiracetam Extended Release Tablets (Sun Pharma) – Dissolution Failure (2015)

Failed Dissolution Specifications: 6 month time point.

Class IIModerate

FDAJan 21, 2015Nationwide• Sun Pharma Global Fze