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 Pharma is recalling a generic drug indicated to raise blood pressure in adult patients with acute hypotension.
Sun Pharma is recalling 16,450 vials of Norepinephrine Bitartrate Injection for “failed impurities/degradation specifications”, it said.
The affected lot has been manufactured by Gland Pharma and distributed in the US by Sun Pharma, the USFDA stated. Sun Pharma initiated the Class III nationwide recall (US) on March 29 this year.
In a separate disclosure, USFDA informed that the US-based arm of Hetero Labs is recalling a drug used to treat certain stomach and oesophagus problems
Hetero US is recalling 2,352 bottles of Pantoprazole Sodium delayed-release tablets for ‘CGMP Deviations: Discoloration’, the US FDA stated. The affected lot was produced by Hetero Labs for Camber Pharmaceuticals, it added.
Hetero USA initiated the Class II recall on March 14 this year.
As per the USFDA, a Class II recall is initiated in a situation where the 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.
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