Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC
Summary
The FDA issued a Class III for Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by Lundbeck LLC. Reason: Cross contamination with other products.
Details
Source
Drug Recall
External ID
D-1142-2023
Action Date
2023-09-06
Status
Completed
Category
drug
Product Description
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Lot/Code Info: Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
Quantity Affected: 10,543 cartons
Reason for Recall
Cross contamination with other products
Distribution
Nationwide within the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-17
Company
Deerfield, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 64 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lundbeck LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lundbeck LLC have FDA actions?
This is the only FDA action we have on record for Lundbeck LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1142-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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