Dr Reddy's recalls over half a million Famotidine tablet bottles in US

Dr Reddy's Laboratories Limited has initiated a nationwide recall of over half a million bottles of Famotidine tablets, 10 mg, in the US after the drug failed impurities/degradation specifications in routine stability testing, according to the US Food and Drug Administration (US FDA).

Famotidine tablets are an over-the-counter product used to treat and prevent ulcers in the stomach and intestines. The company initiated the voluntary recall, which is still underway, of the product in multiple lots on October 3. 

The action was classified as a Class-III recall, meaning the products being recalled are unlikely to cause any adverse health reaction but violate FDA labelling or manufacturing laws.

"Famotidine 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," the drug regulator said. These are 30-count bottles numbering 569,376 across multiple lots, according to the information available on the FDA website.

This is the third product recall by Dr Reddy's this year. Earlier in June, it had taken out 325,000 cartons of Zenatane (isotretinoin) capsules, used in the treatment of acne, from the US market owing to failed dissolution specifications. This product was manufactured by Cipla at its Pune facility for Dr Reddy's.

In February, the Hyderabad-based drug major reported recalling 5,904 bottles of the schizophrenia drug Olanzapine, each containing 30 tablets. These two events, too, were Class-III recalls.