Class I · High risk Completed
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc…
Reason Defective Container: powder may leak out of the pouch
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross contamination with other products
What was recalled
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
- Recalling firm
- Lundbeck LLC
- NDC code
- 67386-211-65
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1142-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Vigabatrin recalls
See all
Class II · Moderate risk Terminated
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
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