Drug & medication recalls Moderate risk

Sun Pharma Global Fze recalls Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd…

Recall date
January 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0386-2015
FDA classification
Class II
Brand / firm
Sun Pharma Global Fze
Sold / distributed
Nationwide.

Why it was recalled

Failed Dissolution Specifications: 6 month time point.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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