4 February 2019 - - Indian drugmaker Dr. Reddy's Laboratories Ltd.'s (BSE: 500124, NSE: DRREDDY) (NYSE: RDY) Dr Reddy's Laboratories, Inc US subsidiary is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in USA, the company said.

This recall, which began in October 2018, was originally initiated due to a product complaint received for mislabeling.

The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as Levetiracetam in 0.75% Sodium Chloride Injection (1000mg/100ml).

Dr. Reddy's said the label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1500mg/100ml).

To date, there have been no reports of adverse events related to this recall.

Patients who may have been administered the mislabeled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma related to over dosage.

Levetiracetam Injection is an antiepileptic drug indicated for adjunct therapy in adults (more than 16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures in patients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.

The batch was distributed in USA between August 14, 2018 and September 5, 2018.

Dr Reddy's Laboratories, Inc has notified the distributors to arrange for return of any recalled product. Wholesalers, distributors, hospitals and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement/etc. of all recalled products.

Wholesalers, distributors and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

Dr. Reddy's Laboratories is an integrated pharmaceutical company, whose major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

The company operates in markets across the globe. Its major markets include USA, India, Russia and CIS countries, and Europe.