Nationwide Recall of Children’s Seizure Medication - MedWaste Management Nationwide Recall of Children’s Seizure Medication - MedWaste Management

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Nationwide Recall of Children’s Seizure Medication

The FDA has issued an urgent recall of a single batch of Vigabatrin for Oral Solution, USP 500mg/sachet. Integrity issues were found on the seal of the children’s seizure medication that may lead to leakage of the medication and, therefore, inaccurate dosing. All patients and/or their guardians must immediately confirm if their batch of medication is affected and seek a replacement if so.

As of the writing of this notice, the FDA has not reported any adverse events related to this recall.

SUMMARY

Date of Recall:

Announced: December 9, 2023

Public Notification: December 11, 2023

Name(s) of Drug:

Vigabatrin for Oral Solution, USP 500mg

Company Name:

Cipla Limited

InvaGen Pharmaceuticals Inc.

Drug Indication:

Seizures in Children

 

Product Description

Pharmacies nationwide distribute Vigabatrin. The medication is packaged in individual foil pouches. Each shelf pack contains 50 pouches.

Reason for Recall

Due to integrity issues, the pouch may not effectively contain the drug. Therefore, the amount of medication remaining in the pouch at the time of dispensing may be less than is intended. This can lead to children receiving less than the prescribed dose of their medication.

Impacts

Consumers who give the medication to their children may find that the child receives a lower dose than is prescribed. This may lead to breakthrough seizures or a return of symptoms altogether. Vigabatrin is sometimes used in conjunction with Phenytoin as it can reduce the levels of Phenytoin circulating in the blood. Especially in patients who are more fragile, sudden changes in their Phenytoin blood levels may be life-threatening.

Lot Information

Consumers who use (or whose children use) Vigabatrin should locate their medication and compare the NDC number, batch number, and expiration date to those below. See below for further instructions if your medication is included in this recall.

Product Description
NDC Number
Batch Number
Expiration Date
Vigabatrin for Oral Solution, USP 500mg/sachet

6909-7964-53

NB301030

03/2025

FDA.gov

Have you found that your (or your child’s) medication is part of the recall? Here’s what you should do:

Consumers

  1. Immediately notify your doctor (if you use the medication), or your child’s doctor/pediatrician if they use the medication.
  2. Request a new prescription to replace the recalled medication and report any changes in your or your child’s health.
  3. Continue to monitor your/your child’s health for any adverse symptoms and notify your doctor or your child’s doctor if any concerns are noted.
  4. Consumers may contact Cipla at 1-844-247-5287. They are available Mon-Fri from 8:30 a.m. to 5:00 p.m. (EST). You can also contact them via email at cipla.cs@cipla.com.
  5. If you or your child is currently experiencing or has experienced an adverse reaction to the medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Cipla at 1-844-247-5287, or you can utilize cipla.cs@cipla.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Cipla at 1-844-247-5287, or you can utilize cipla.cs@cipla.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse Writer

 

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!


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