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DRL recalls Famotidine tabs from US market

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The drug is an OTC product used to treat and prevent ulcers in stomach and intestines

Dr Reddy’s Laboratories (DRL) has initiated voluntarily recall of over half a million Famotidine tablets bottles from the US market as the drug failed impurities or degradation specifications.

According to a notification put up by the US 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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