Dr Reddy's Laboratories recalls 2,770 bags of epilepsy injection in US

22 Feb 2019 Evaluate

Dr Reddy's Laboratories is recalling 2,770 bags (277 selling units) of epilepsy drug Levetiracetam Sodium Chloride injection in the US market, on account of a labelling error.  The company is recalling Levetiracetam in 0.54 percent Sodium Chloride injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags. The product is being recalled by Dr Reddy's US-based subsidiary, and has been manufactured by Hyderabad-based Gland Pharma.

The reason for recall is the pre-printed text on the primary infusion bag and the national drug code (NDC) incorrectly identifies the product as Levetiracetam in 0.75 percent Sodium Chloride (1000 mg/100 mL), however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54 percent Sodium Chloride injection (1,500/100 mL).

Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.


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