USFDA norms violation: Lupin recalls 12,888 bottles of ulcer drug

Famotidine for oral suspension is used for short-term treatment of active duodenal ulcer, active benign gastric ulcer and gastroesophageal reflux disease

Drug firm Lupin's US arm, Lupin Pharmaceuticals Inc, is recalling 12,888 bottles of Famotidine for oral suspension used in treatment of ulcers from the American market.

The reason for the recall is current Good Manufacturing Practise (CGMP) deviations, United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Lupin Pharmaceuticals Inc is recalling 12,888 bottles of Famotidine for oral suspension USP, 40 mg/5 ml, 50 ml bottle, manufactured by Lupin Ltd at its Goa facility, it added.

The ongoing nation wide voluntary recall is a class III recall, the report said.

Famotidine for oral suspension is indicated in short-term treatment of active duodenal ulcer, active benign gastric ulcer and gastroesophageal reflux disease.
 

As per the US FDA, a class III recall is initiated in "a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".