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Sun Pharma Global Fze Recalls
4 recalls on record · February 18, 2015 to March 9, 2016 · Drugs
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 9, 2016DrugsFDA
Sun Pharma Global Fze recalls Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind.
Hazard: Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
August 26, 2015DrugsFDA
Sun Pharma Global Fze recalls buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed
Hazard: 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.
March 4, 2015DrugsFDA
Sun Pharma Global Fze recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratori
Hazard: Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
February 18, 2015DrugsFDA
Sun Pharma Global Fze recalls Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd H
Hazard: Failed Dissolution Specifications: 6 month time point.