Hyderabad-based Dr Reddy’s, Lupin recall products in US due to labelling, manufacturing errors
As per its latest Enforcement Report, 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.
New Delhi: Dr Reddy’s Laboratories and Lupin are recalling products in the US market due to labelling and manufacturing errors, respectively, according to the US health regulator.
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.
