Top
Begin typing your search above and press return to search.
keyboard_arrow_down
Login
exit_to_app
Going beyond birthday celebration
access_time 18 Sep 2020 6:05 AM GMT
Periyar@142-Revolutionary and Visionary
access_time 17 Sep 2020 11:57 AM GMT
The word of caution from the highest court
access_time 17 Sep 2020 6:31 AM GMT
access_time 16 Sep 2020 5:58 AM GMT
access_time 15 Sep 2020 6:19 AM GMT
DEEP READAll arrow_drop_down
The ogres in the mind
access_time 8 Sep 2020 11:27 AM GMT
Why worry about populism?
access_time 4 Sep 2020 9:51 AM GMT
Media mind-set towards minorities
access_time 15 July 2020 4:29 PM GMT
exit_to_app
Homechevron_rightBusinesschevron_rightDr Reddys recalls...

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

text_fields
bookmark_border
Dr Reddys recalls 2,770 bags of epilepsy injection in US
cancel

New Delhi:  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.

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.

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 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.

Show Full Article
TAGS:
Next Story