Drug Enforcement D-1142-2023

Cross contamination with other products

Status

Completed

Classification

Class III

Report Date

September 6, 2023

Termination Date

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Product Information

Product description
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Product quantity
10,543 cartons
Reason for recall
Cross contamination with other products
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the U.S.

Location & Firm

Recalling firm
Lundbeck LLC
Address
6 Parkway North Blvd Ste 400, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1142-2023
Event ID
92894
Recall initiation date
August 17, 2023
Center classification date
August 29, 2023
Code info
Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
More code info
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