The move comes after US FDA found quality issues like ‘discolouration’ and presence of brown pellets in the company’s 40 mg Esomeprazole Magnesium delayed-release capsules
Dr Reddy’s Laboratories is recalling 1,752 bottles of generic heartburn medicine in the US after the American health regulator found quality issues with the product.
As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), the Hyderabad-based drug firm is voluntarily recalling 1,752 bottles (1,000 count) of 40 mg Esomeprazole Magnesium delayed-release capsules in the US.
The ongoing Class III recall is on account of “discolouration” and because the product contains brown pellets, USFDA said.
As per the US health regulator, 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”.
The recalled product lot has been manufactured at Dr Reddy’s Bachupally manufacturing facility in Telangana and is being recalled by the company’s US-based arm.
Esomeprazole Magnesium delayed-release capsules are indicated to reduce the amount of acid in the stomach and other symptoms associated with gastroesophageal reflux disease (GERD).
In February last year, the company had announced the recall of 20,78,490 bottles of Esomeprazole Magnesium delayed-release capsules in the US market