Class III · Low risk Completed
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC…
Reason Cross contamination with other products
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Container: powder may leak out of the pouch
What was recalled
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 69097-964-53
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0220-2024
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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