Sun Pharma Global Fze recalls
FDA enforcement reports naming Sun Pharma Global Fze as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Mar 9, 2016
- Mar 9, 2016Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufact…Drug · Sun Pharma Global FzeFailed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.Class II
- Aug 26, 2015buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx On…Drug · Sun Pharma Global FzeFailed 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 III
- Mar 4, 2015Ketorolac Tromethamine Ophthalmic Solution, 0Drug · Sun Pharma Global FzePresence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.Class II
- Feb 18, 2015Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured…Drug · Sun Pharma Global FzeFailed Dissolution Specifications: 6 month time point.Class II