Pharmaceutical Recalls Shake Industry with Contaminant Concerns
Major pharmaceutical companies Glenmark, Alembic Pharmaceuticals, and Sun Pharma recall products in the US due to manufacturing issues. The recalls involve issues like nitrosamine impurities and the presence of foreign substances. The USFDA has classified these as Class II recalls, indicating the potential for temporary or medically reversible health consequences.
- Country:
- India
In a notable development impacting the pharmaceutical sector, Glenmark, Alembic Pharmaceuticals, and Sun Pharma are pulling specified products off the U.S. market. This action follows findings by the USFDA of manufacturing discrepancies, including contaminants like nitrosamine impurities and foreign substances.
Glenmark is recalling over 55,000 units of Carvedilol tablets due to nitrosamine levels exceeding acceptable intake. As part of a Class II recall, Glenmark has also started pulling Theophylline tablets due to dissolution failures.
Alembic Pharmaceuticals and Sun Pharma face similar challenges, with nitrosamine impurities and foreign substance detection in their recalled products. The USFDA's classifications indicate these recalls could prevent temporary health issues but aren't likely to cause serious adverse effects.
(With inputs from agencies.)
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