FDA-Drug2015-02-18Class II

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

Sun Pharma Global Fze
Hazard

Failed Dissolution Specifications: 6 month time point.

Sold states
Nationwide.
Affected count
3263 bottles
Manufactured in
Office # 43 Block Y Saif Zone, N/A, Sharm, N/A, United Arab Emirates
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2015

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