Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in Sodium Chloride
Dr. Reddy’s Laboratories Ltd.’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.
The 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). 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 inpatients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.
The batch was distributed in U.S.A. between August 14, 2018 and September 5, 2018.
- Levetiracetam in 0.54% Sodium chloride Injection, 1500mg/100mL
- Manufacturer: Gland Pharmaceuticals
- NDC: 43598-637-52
- Lot: ABD807
- Expiry Date: /2020
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. For instructions on returning product or additional assistance, call Inmar at 1-800-967-5952 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
If patients have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 10 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program.
This recall is being executed with the knowledge of the U.S. Food and Drug Administration. See the recall notice for additional information, including important safety information for Levetiracetam in Sodium Chloride Injection.
Want to read the full alert and receive alert emails?