Lupin, Zydus Pharmaceuticals Recall Products In U.S.
An employee holds capsules for a photograph inside a coating unit at the Lupin Ltd. pharmaceutical plant in Salcette, Goa, India. (Photographer: Dhiraj Singh/Bloomberg)

Lupin, Zydus Pharmaceuticals Recall Products In U.S.


Drug major Lupin Ltd. is recalling 46,700 bottles of Morphine Sulfate extended-release tablets—used to treat severe pain—in the U.S. market, according to a report by the U.S. Food and Drug Administration.

Lupin Somerset is recalling the drug in various strengths due to “failed impurities/degradation specifications”, the latest enforcement report by the U.S. FDA said.

“Product was shipped to five wholesalers and one supermarket chain who may have further distributed the product throughout the U.S.,” it added.

Zydus Pharmaceuticals USA Inc., a subsidiary of Zydus Cadila Ltd., is also recalling 7,668 bottles of Carvedilol Tablets, used to treat high blood pressure. The drugmaker is recalling the drug due to the “presence of foreign tablets/capsules”, U.S. FDA said.

Also read: Lupin Falls After U.S. FDA Classifies Pithampur Unit For Official Action

“Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125 mg,” it added.

The U.S. FDA classified both the recalls as Class III.

A Class III recall by the U.S. FDA is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Also read: Lupin Recalls Over 12,000 Cartons Of Birth Control Tablets From U.S. Market

BQ Install

Bloomberg Quint

Add BloombergQuint App to Home screen.