Around 3.8 lakh cartons of an osteoporosis drug manufactured by Sun Pharmaceutical Industries are being recalled in the US and Puerto Rico due to presence of ‘unknown impurity’.
The recall of 3,81,120 cartons of Alendronate Sodium tablets has been initiated by Sun Pharma Global Fze, an arm of the Indian pharma major.
The drug is manufactured at Sun Pharma’s Halol facility in Gujarat, United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The cartons are being recalled on account of “observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point,” the report said.
The ongoing recall falls under Class II, which is initiated “in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” it said.
Alendronate Sodium tablets are used for treatment of osteoporosis in postmenopausal women. Last year in December, Sun Pharma had said it had received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat and the US health regulator had withheld future product approvals from the facility.