Drugmakers Glenmark Pharmaceuticals Ltd., Sun Pharmaceutical Industries Ltd. and Zydus are recalling products in the US for manufacturing issues, the Food and Drug Administration said in its latest Enforcement Report.
As per the US health regulator, Mumbai-based Glenmark is recalling over 25 products in the US market due to Current Good Manufacturing Practice deviations.
New Jersey-based Glenmark Pharmaceuticals Inc. is recalling affected lots of medications like Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets in America, the FDA said.
It is also recalling products like Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13 this year.
As per the FDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
A US-based subsidiary of Sun Pharma is recalling around 13,700 bottles of Gabapentin capsules, a medication used to treat and prevent seizures in people with epilepsy.
New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot due to 'Cross Contamination', the USFDA said. The company initiated the Class III recall on March 4, 2025.
The US health regulator said Zydus Pharmaceuticals (USA) Inc. is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10 mg, a medication used to treat mental health conditions, like schizophrenia and bipolar disorder.
The drug firm is recalling the affected lot due to CGMP deviations, the USFDA said.
There was "presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit", it added. The company initiated the Class II recall on April 3, 2025.
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