Vigabatrin Oral Solution Recalled for Manufacturing Quality Deviations
Accord Healthcare is recalling 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall for manufacturing quality deviations without reported illnesses, injuries, or deaths. CGMP deviations represent manufacturing process issues addressed through precautionary recalls when no specific harm has been identified, qualifying this as a Moderate severity recall.
Plain-English summary
Accord Healthcare, Inc. is recalling Vigabatrin for Oral Solution, USP, 500 mg, in the United States, Puerto Rico, and Canada due to manufacturing quality deviations identified during a U.S. Food and Drug Administration inspection. Vigabatrin is a prescription medication used in seizure management.
The recall affects 821 cartons of batch R2100308 with an expiration date of February 28, 2023, manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India. This is a Class II recall.
Patients with this medication should verify their batch number and contact their healthcare provider if they possess the recalled product.
The recalled product
- Product
- Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC…
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- Affected units
- 821
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)
- Batches: R2100308
- Exp. Date 2/28/2023
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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