New Delhi, Feb 21 (PTI) Drug major 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.Also Read - US Eases Travel Restrictions on India Amid Dip in COVID Cases, Lowers Advisory to Level 3 | Here's What it Means
According to the latest Enforcement Report of the US Food and Drug Administration (USFDA), the drug firm is recalling Levetiracetam in 0.54 per cent Sodium Chloride injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags. Also Read - Hyderabad Couple Donates Golden Sword Worth Rs 4 Crore to Tirupati Balaji Temple | See Pics
The product is being recalled by Dr Reddy’s US-based subsidiary, and has been manufactured by Hyderabad-based Gland Pharma. Also Read - Inspiring! This Hyderabad Couple Has Been Fixing Potholes From Pension Money Since The Last 11 Years
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 per cent Sodium 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 Class-I. Such recalls are for dangerous or defective products that predictably can cause serious health problems.
Levetiracetam injection is an anti-epileptic drug indicated for adjunct therapy in adults on certain types of seizures 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.
This is published unedited from the PTI feed.