Hyderabad: Dr Reddy’s Laboratories has decided to voluntarily recall over half a million (five lakh) Famotidine tablets bottles from the US market after the drug failed the country’s drug administrator’s quality requirements.
Famotidine is an over-the-counter (OTC) product used to treat and prevent ulcers in stomach and intestines. This is the third product recall by Dr Reddy’s in 2017. The others being 325,000 cartons of Zena-tane capsules in June and 5,904 bottles of Olanzapine in February.
Explaining the reasons for the recall, the US Food and Drug Administration (FDA) said: “Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance obser-ved during routine stability testing of a batch for related substances — impurity 8 at 24 month stability interval.”
The notification said that the recall is being made under ‘Class-III’ classification. According to the US FDA guidelines, a recall under Class-III classification would mean the use of such drug may not cause adverse health consequences.