Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86

Recall Number: D-0386-2015

Firm: Sun Pharma Global Fze

Classification: Class II

Status: Terminated

Report Date: 20150218

Initiation Date: 20150121

Termination Date: 20151023

Failed Dissolution Specifications: 6 month time point.

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86