Sabril Powder, For Solution
FDA Recall NDC 67386-211
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sabril (NDC 67386-211). A significant event, classified as Class III, was initiated on Aug 17, 2023 by Lundbeck Pharmaceuticals Llc. The reported reason for this action was: "Cross contamination with other products"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Cross contamination with other products
Aug 17, 2023
Sep 06, 2023
10,543 cartons
Recall Profile & Regulatory Data
Event ID
92894
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Lundbeck LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S.
Product Description
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Batch or Lot Expiration Information
Lot# : 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
Affected Packages Involved in this Recall
67386-211-65Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
