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Recall Observatory FDA recall evidence

Drug product

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

D-1142-2023

August 17, 2023

Class III

Product summary

Firm
Lundbeck LLC
Event
Event 92894
Status
Completed
Classification
Class III
Quantity
10,543 cartons
Official record key
drug-enforcement:D-1142-2023

Official wording

Reason: Cross contamination with other products

Code information: Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .

Distribution pattern: Nationwide within the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross contamination with other products