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

FDA recall notice · announced February 18, 2015 · Sun Pharma Global Fze

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Failed Dissolution Specifications: 6 month time point.

Notes

Distribution: Nationwide.
Lot/code information: Lot #: JKN0249A Exp 02/2016
Quantity: 3263 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0386-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.