Hetero, Sun Pharma recall products in US over manufacturing issues
Hetero USA Inc is recalling 2,352 bottles of Pantoprazole Sodium delayed release tablets for "CGMP Deviations: Discoloration", the USFDA stated.
New Delhi: Drug makers Sun Pharma and Hetero are recalling products in the US market for manufacturing issues, according to the US Food and Drug Administration (USFDA). As per the US health regulator's latest Enforcement Report, the US-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 US by Sun Pharmaceutical Industries, the USFDA stated. Sun Pharmaceutical Inc initiated the Class III nationwide recall (US) on March 29 this year.
As per the USFDA, 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 USFDA said the US-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 USFDA 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 USFDA, 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 US is the world's largest market for pharmaceutical products.
Read also: Sun Pharma recalls over 34000 bottles of generic medication in US due to failed dissolution testing
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