Prescription Vigabatrin Powder Recalled for Defective Container Leakage Risk
InvaGen Pharmaceuticals recalls Vigabatrin for Oral Solution nationwide due to defective containers that may leak. Consumers with affected lot should contact their pharmacy or healthcare provider.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I drug recall, which per regulatory guidance cannot be scored below Severe (4). The defect involves containers that may leak, risking incomplete dosing and product loss or contamination.
Plain-English summary
InvaGen Pharmaceuticals, a subsidiary of Cipla Ltd., is recalling Vigabatrin for Oral Solution, USP 500 mg per packet, due to defective containers. The powder packets may leak, potentially resulting in loss of medication or exposure of the product to contamination.
The affected product is limited to Lot #NB301030 with an expiration date of 03/31/2025. Approximately 1,240 boxes were distributed nationwide within the United States under NDC 69097-964-53.
Vigabatrin is a prescription anti-epileptic medication used to treat seizures. A defective container that allows powder to leak may prevent patients from receiving their full prescribed dose, potentially affecting treatment effectiveness. Additionally, leaked powder may become contaminated or degraded if exposed to air or moisture.
Consumers who have the affected product should contact their pharmacy or healthcare provider for guidance. The product should not be used.
The recalled product
- Product
- VIGABATRIN (VIGABATRIN)
- Brand
- VIGABATRIN
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug
- Affected units
- 1,240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: NB301030
- Exp. Date 03/31/2025
Distribution
Distributed nationwide across the United States.
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