Alendronate Sodium is a bisphosphonate indicated for the treatment and prevention of osteoporosis in postmenopausal women. An analysis of 3-month long-term stability testing showed that the levels of highest unknown impurity was exceeding the specification limit.
The affected products have Lot# JKP2234A and JKP2235A. Both sets have an expiration date of 04/2017 and are packaged in 4-tablet aluminum blister packs. They were distributed between September 2015 and November 2015.
Healthcare providers are to immediately quarantine any affected lots and cease distribution.
For more information call (800) 967-5952 or visit SunPharma.com.