Dr Reddy's, Lupin recall drugs in US over labeling, manufacturing flaws

The US health agency has announced that Lupin and Dr. Reddy's Laboratories are recalling items in the US market because of manufacturing and labeling mistakes, respectively. A US-based subsidiary of the Hyderabad-based pharmaceutical giant is recalling specific batches of a generic antiepileptic medication in the US market, according to the US Food and Drug Administration's (USFDA) most recent Enforcement Report.According to the USFDA, 4,010 bags of Levetiracetam 0.75 pc in Sodium Chloride Injection (1,000 mg/100 mL) from Princeton-based Dr. Reddy's Laboratories, Inc. are being recalled in the US because of a labeling error."The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly and critical step which is to identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL," it added.

According to the US health agency, the corporation announced the Class 1 countrywide (US) recall on March 13 of this year. A Class I recall, according to the USFDA, concerns faulty items that have the potential to cause major health issues. An antidepressant drug used to treat obsessive-compulsive disorder this clinical practices being recalled by a US-based subsidiary of Mumbai-based Lupin, according to a separate filing by the US health authorities.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.