Express Pharma

DRL recalls Famotidine tabs from US market


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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