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
Is Vigabatrin recalled?
3 FDA recalls mention Vigabatrin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Vigabatrin.
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
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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