
According to the USFDA, a class II retreat begins when the probability of serious advertising health results is minimal
Genmark, Sun Pharma and Zydus drug manufacturers are withdrawing products in the United States due to manufacturing problems, said the United States drug and food administration (USFDA) in the latest application report.
According to the US Health Regulator, Glenmark, based in Mumbai, is a recovery of more than 25 products in the US market due to good deviations of good manufacturing practices (CGMP).
Glenmark Pharmaceuticals INC, based in New Jersey, is affected by many medications such as extended release capsules of propaphaenone hydrochloride and solifenacine succinate tablets in the United States, the USFDA said.
They are also recovery products such as Voriconazole tablets, Lacosamide tablets, Frovatriptan succinate tablets and rufinamide tablets. The company began the retirement of class II on March 13 of this year.
According to the USFDA, a class II retreat begins when the use or exposure to a rapist product can lead to temporary or medically reversible health consequences, or when the probability of serious advertising health results is minimal.
A Sun Pharma subsidiary based in the United States is a recovery of around 13,700 bottles or capsules of Gabapentina, a medication used to treat and prevent seizures in people with epilepsy.
Sun Pharmaceutical Industries Inc, based in New Jersey, is the affected lot due to the ‘Cross Pollution’, said the USFDA. The company began the retirement of class III on March 4, 2025.
The US health regulator
The pharmaceutical company is the affected lot due to CGMP deviations, said the USFDA.
There was “presence of the n-nitroso-demethyl impurity chlorpromazine above the recommended provisional limit,” he added. The company started class II retirement on April 3, 2025.
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Posted on April 13, 2025