Hyderabad, Oct 20 (PTI) Dr Reddy's Laboratories hasinitiated voluntarily recall of over half a million Famotidinetablets bottles from the US market as the drug failedimpurities or degradation specifications.
According to a notification put up by the US Food andDrug Administration, the recall is being made under'Class-III' classification, which is described as 'a situationin which use of or exposure to a violative product is notlikely to cause adverse health consequences'.
"Failed impurities/degradation specifications:Famotodine has an out of specification result for anindividual related substance observed during routine stabilitytesting of a batch for related substances -impurity 8 at 24month stability interval," the notification said on thereasons for recall.
As many as 5,69,376 bottles of Famotidine tablets, 10mg belonging to multiple lots packaged in 30-count, are beingrecalled nationwide.
The drug is an over-the-counter (OTC) product used totreat and prevent ulcers in stomach and intestines. PTI GDKGK.
This is unedited, unformatted feed from the Press Trust of India wire.