Recall Continuing for Seizure Treatment Drug

Dr. Reddy’s Laboratories is continuing its voluntary nationwide recall of the antiepileptic drug Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) in single-dose infusion bags to the hospital level in the United States. This recall involves lot ABD807, which was distributed in the US between August 14, 2018 and September 5, 2018.

The recall, which began in October 2018, was initiated due to a product complaint for mislabeling. The preprinted text content on the infusion bag for the lot indicates product information as Levetiracetam in 0.75% Sodium Chloride Injection (1000mg/100ml). However, the label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1500mg/100ml).

To date, there were no reports of adverse events related to this product.

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 indicated for adjunct therapy in patients aged 16 years and older with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures inpatients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.

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. 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.

For instructions on returning product or additional assistance, call Inmar at 1-800-967-5952.

Reference

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling [news release]. Hyderabad, India and Princeton, New Jersey; February 4, 2019: Dr. Reddy's Laboratories. https://www.businesswire.com/news/home/20190203005054/en/Dr.-Reddys-Laboratories-Continues-Voluntary-Nationwide-Recall. Accessed February 4, 2019.