Sun Pharma, Hetero Recall Drugs In The U.S. Market

Drug makers Sun Pharma and Hetero are recalling products in the U.S. market for manufacturing issues, according to the U.S. Food and Drug Administration.

As per the U.S. health regulator's latest Enforcement Report, the U.S.-based arm of Sun Pharmaceutical Industries is recalling a generic drug indicated to raise blood pressure in adult patients with acute hypotension.

Princeton (New Jersey) based Sun Pharmaceutical Inc is recalling 16,450 vials of Norepinephrine Bitartrate Injection for "Failed Impurities/Degradation Specifications", it said.

The affected lot has been manufactured by Hyderabad-based Gland Pharma and distributed in the U.S. by Sun Pharmaceutical Industries, the U.S. FDA stated. Sun Pharmaceutical Inc. initiated the Class III nationwide recall (U.S.) on March 29 this year.

As per the U.S. 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".

In a separate disclosure, the U.S. FDA said the U.S.-based arm of Hetero Labs is recalling a drug used to treat certain stomach and esophagus problems.

Hetero USA Inc is recalling 2,352 bottles of Pantoprazole Sodium delayed release tablets for 'CGMP Deviations: Discoloration', the U.S. FDA stated.

The affected lot was produced by Hetero Labs for New Jersey-based Camber Pharmaceuticals Inc., it added.

Hetero USA Inc initiated the Class II recall on March 14 this year.

As per the U.S. FDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The Indian pharmaceutical industry is the world's third-largest by volume and 14th-largest in terms of value. India exported pharmaceuticals worth Rs 1,75,040 crore in the financial year 2021-22, including bulk drugs/ drug intermediates.

The U.S. is the world's largest market for pharmaceutical products.