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Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

February 4, 2019

Audience: Health Professional, Pharmacy

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’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.

The recalled batch is as follows:

Item Description Manufacturer NDC Lot Expiry
Date
Levetiracetam in 0.54% Sodium chloride Injection, 1500mg/100mL Gland Pharmaceuticals 43598-637-52 ABD807 05/2020

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 either by phone, on line, by regular mail or by fax.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Important Safety Information: Levetiracetam in Sodium Chloride Injection

What important information should I know about Levetiracetam in Sodium Chloride Injection?

Who should not use Levetiracetam in Sodium Chloride Injection?

What should I tell my healthcare provider before taking Levetiracetam in Sodium Chloride Injection?
Before taking Levetiracetam in Sodium Chloride Injection, tell your healthcare provider if you:

Tell your healthcare provider about all medications and herbal products you take, including prescription and over-the-counter medications, vitamins and herbal supplements.

What are possible side effects of Levetiracetam in Sodium Chloride Injection?

These are not all the possible side effects of Levetiracetam. Please refer to the Package Insert for a complete list of possible side effects.
Call your healthcare provider right away if you have any of the following:

The most common side effects of Levetiracetam in Sodium Chloride Injection?

What should I avoid while taking Levetiracetam in Sodium Chloride Injection?

For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Call Center at 1-888-DRL-DRUG (1-888-375-3784) or via email to medinfo@drreddys.com or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/index.cfm.

Indication and Usage
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of:

Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose 100 mL dual port bag with an aluminum overwrap.

Source: FDA

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