FDA-Drug2016-03-09Class II
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.
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.
Sold states
Nationwide and Puerto Rico
Affected count
381,120 cartons
Manufactured in
Office # 43 Block Y Saif Zone, N/A, Sharm, N/A, United Arab Emirates
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0735-2016Don't want to check this manually?
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