Sun Pharma Global Fze recalls Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind.
Recalled March 9, 2016 · FDA recall D-0735-2016 · Sun Pharma Global Fze
Hazard
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. · FDA Class II
Units
381,120 cartons
Sold at
Nationwide and Puerto Rico
Description
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Product
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Manufacturer(s)
Sun Pharma Global Fze
Made in
United Arab Emirates
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →