Mumbai: Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma, on Wednesday said in a statement it has recalled from the market a product manufactured at its Detroit facility, used to treat heart problems.
The withdrawal of the product Digoxin has been voluntary, Caraco said, adding it is being recalled because of possible variation in the sizes of the tablets.
“The recall is being conducted with the knowledge of the (US) Food and Drug Administration,” the statement said.
Caraco said the sales revenue of the affected lots is approximately $3 million.
Sun Pharma has a 76% stake in Caraco and it is listed on the US bourses.
The company said the recall would not impact other products manufactured and distributed by it from the Detroit facility.