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Indian pharmaceutical giant Cipla is recalling Esomera's magnesium intestinally soluble oral dry suspension in doses of 10 mg, 20 mg and 40 mg, respectively, in more than 580,000 bags, according to a new FDA law enforcement report.
the affected drugs were produced at Sipra's plant in Kurkumbh, Maharashtra, India, and then supplied to Sipra's New Jersey subsidiary.
the U.S. FDA reported in a report that the drugs were cross-contaminated with other products at the time of production, and that the drug accessories used as an agent were contaminated with acetaminophen.
recall was carried out throughout the U.S. last month, and the FDA classified it as a secondary recall.
fda, a secondary recall is initiated if the use or exposure to the nonconforming drug may result in temporary or medically reversible health hazards, or if the likelihood of serious health hazards is less likely.
Indian drug companies that have recently been recalled in the U.S. are not the only ones in Sepra, and another FDA statement said that since last month, Bangalore, India-based Strides Pharmaceuticals inc. began recalling 960 100 mg-sized thokmos capsules in the U.S. because of substandard moisture, a level 3 recall defined by the FDA as an unlikely health hazard from use or exposure to the nonconforming drug.
