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Dr Reddy's, Lupin recall products in US due to manufacturing errors: USFDA
As per its latest Enforcement Report, US Food and Drug Administration (USFDA) said a US-based subsidiary of the Hyderabad-based drug major is recalling certain batches of a generic antiepileptic drug in the US market.
Princeton-based Dr Reddy's Laboratories, Inc is recalling 4,010 bags of Levetiracetam 0.75 pc in Sodium Chloride Injection (1,000 mg/100 mL) in the US due to labelling mix up, USFDA said.
"The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL," it added.
The company has issued the Class 1 nationwide (US) recall on March 13 this year, the US health regulator noted.
As per the USFDA, a Class I recall pertains to defective products that can cause serious health problems.
In a separate filing, the US health regulator said that a US-based subsidiary of Mumbai-headquartered Lupin is recalling an antidepressant medication which used in the treatment of obsessive-compulsive disorder.
Naples-based Lupin Pharmaceuticals Inc is recalling 2,724 bottles of clomiPRAMINE hydrochloride Capsules USP, 25 mg, due to "Failed Impurities/Degradation Specifications", USFDA said.
The company initiated the Class II recall on April 18, it added.
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