Dr. Reddy’s Laboratories has initiated a voluntarily recall of more than half a million Famotidine tablet bottles from the U.S. market as the drug failed impurities or degradation specifications.
According to a notification put up by the U.S. Food and Drug Administration, the recall is being made under ‘Class-III’ classification, which is described as ‘a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences’.
“Failed impurities/degradation specifications: Famotidine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances — impurity 8 at 24 month stability interval,” the notification said on the reasons for recall.
As many as 5,69,376 bottles of 10 mg Famotidine tablets, belonging to multiple lots packaged in 30-count, are being recalled nationwide.
The drug is an over-the-counter (OTC) product used to treat and prevent ulcers in stomach and intestines.
