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Dr Reddy's recalls 2,770 bags of epilepsy drug in US over labelling error

Such recalls are for dangerous or defective products that predictably can cause serious health problems

Press Trust of India  |  New Delhi 

reddy, dr reddy's
Dr Reddy's laboratory

Drug Dr Reddy's Laboratories is recalling 2,770 bags (277 selling units) of drug Chloride injection in the US market, on account of a labelling error.

According to the latest Enforcement Report of the (USFDA), the drug firm is recalling in 0.54 per cent 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

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 in 0.75 per cent Chloride (1000 mg/100 mL), however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54 per cent Sodium Chloride injection (1,500/100 mL)."

The ongoing voluntary nationwide recall has been classified as recalls are for dangerous or that predictably can cause serious health problems.

Levetiracetam injection is an anti-epileptic drug indicated for adjunct therapy in adults on certain types of when oral administration is temporarily not feasible.

Dr Reddy's is also recalling 20,78,490 bottles of Esomeprazole Magnesium delayed-release capsules, used in treating certain stomach and oesophagus problems, in the US market.

The US health regulator is yet to decide on the classification of the recall.

Dr Reddy's shares were trading at Rs 2,552.05 apiece, up 1.12 per cent from their previous close, on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Thu, February 21 2019. 15:20 IST
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