Takeaways
- InvaGen Pharmaceuticals voluntarily recalls one lot of Vigabatrin for Oral Solution, USP 500 mg due to an improper pouch seal, posing a risk of powder leakage.
- Vigabatrin is used as an adjunctive therapy for refractory complex partial seizures in patients aged 2 years and older.
- The recall mainly affects infants and young children, with potential consequences such as breakthrough seizures or intoxication due to inaccurate dosing.
- Inaccurate dosing may lead to serious adverse effects, including life-threatening seizures requiring emergency treatment for patients with severe or repeated breakthrough seizures.
- As of December 11, 2023, no adverse events related to the recall have been reported, but consumers are urged to initiate the return process through their place of purchase.
The FDA has announced that InvaGen Pharmaceuticals Inc. has voluntarily recalled 1 lot of Vigabatrin for Oral Solution, USP 500 mg due to an improper pouch seal that could allow for powder leakage. potentially causing underdosing.
Vigabatrin for Oral Solution, USP 500 mg is used as an adjunctive therapy to treat refractory complex partial seizures in patients aged 2 years and older who have responded adequately to several alternative treatments. Vigabatrin is not indicated as a first-line treatment.
According to the announcement, the population at risk in mainly infants and young children, as there is a “reasonable probability” that an inaccurate dosing could result in a serious adverse effect such as breakthrough seizures that require medical attention or intoxication.
For patients who could have severe or repeated breakthrough seizures, life-threatening seizures requiring emergency department treatment could result from a drop in their phenytoin blood levels.
As of December 11, 2023, there have been no reports of adverse events related to the voluntary recall.
The medication is packaged in foil pouches that each contain 500mg of Vigabatrin. In a shelf pack, there are 50 pouches. The product was distributed nationwide to partnered distributors and consignees.
NB301030 is the affected lot that has an expiration of March 2025. The NDC number is 6909-7964-53. InvaGen Pharmaceuticals is notifying consumers through press releases, letters, phone calls, emails, and on-site visits. Consumers are advised to begin the return process through their respective place of purchase, and can call 844-247-5287 for questions regarding the recall, or email cipla.cs@cipla.com.
Adverse reactions or quality problems with the product can be reported to the FDA’s MedWatch Adverse Event Reporting program via an online report or regular mail.
Click here to complete an online report.
Reference:
IvaGen Pharmaceuticals issues voluntary nationwide recall of Vigabatrin for Oral Solution, USP 500mg due to leaking sachets. FDA. Press release. December 11, 2023. Accessed December 11, 2023.
