India's Sun Pharma has voluntarily recalled 381,120 cartons of osteoporosis drugs in the United States and Puerto Rico.
The recall is for 3,81,120 cartons of Alendronate Sodium tablets due to "observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point," according to the FDA report.
The drug is manufactured at Sun Pharma's Halol facility in Gujarat. This is the same facility that received an FDA warning letter in December 2015 for significant cGMP violations, including buckets in the parenteral manufacturing space collecting water from overhead leaks.
Sun was aiming to ask the U.S. FDA to re-inspect this Halol facilty in the first quarter of next year.
Read the FDA report