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.
Reason for recall: Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Recall initiated: 20160211
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated