Dr. Reddy's Laboratories Ltd. has initiated voluntarily recall of over half a million Famotidine tablets 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: Famotodine 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 Famotidine tablets, 10 mg 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.
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