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  4. Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

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

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Mislabeling
Company Name:
Dr. Reddy’s Laboratories Ltd.
Brand Name:
Brand Name(s)
Dr. Reddy’s Laboratories Ltd.
Product Description:
Product Description
Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection)

Company Announcement

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?

  • Levetiracetam is an antiepileptic drug indicated for adult patients 16 years of age and older when oral administration is temporarily not feasible.
  • Treatment with Levetiracetam may cause changes in behavior such as aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, and psychotic symptoms.
  • Levetiracetam may cause drowsiness, sleepiness, and fatigue.
  • Levetiracetam may cause serious dermatological reactions. Levetiracetam should be discontinued at the first sign of rash.
  • Levetiracetam should be gradually withdrawn to minimize potential of increased seizure frequency.
  • Levetiracetam blood levels may decrease during pregnancy. It is recommended that patients be monitored carefully during pregnancy.

Who should not use Levetiracetam in Sodium Chloride Injection?

  • Patients with a known hypersensitivity to levetiracetam should not take this drug as angioedema and anaphylaxis have been reported.

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:

  • Have or have had suicidal thoughts or behavior
  • Have or have had kidney problems
  • Become pregnant or intend to become pregnant
  • Are nursing

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?

  • Headache
  • Pain
  • Depression
  • Nervousness
  • Ataxia
  • Vertigo
  • Amnesia
  • Anxiety
  • Pharyngitis
  • Rhinitis
  • Diplopia
  • Fatigue

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:

  • Changes in mood or behavior
  • Signs or symptoms of an allergic reaction or increased swelling
  • Signs or symptoms of a rash

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

  • Drowsiness
  • Sleepiness
  • Fatigue
  • Infection
  • Dizziness

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

  • Avoid driving or operating machinery until you know how levetiracetam affects you as levetiracetam may cause dizziness and sleepiness.

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.fda.gov/medwatch/report.htm.

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:

  • Partial onset seizures in adults with epilepsy,
  • Myoclonic seizures in adults with juvenile myoclonic epilepsy,
  • Primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.

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.

Company Contact Information

Consumers:
Inmar
1-800-967-5952
Media:
Calvin Printer
+91-40-49002121
calvinprinter@drreddys.com
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