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
Reported: February 18, 2015 Initiated: January 21, 2015 #D-0386-2015
Product Description
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.
Details
- Recalling Firm
- Sun Pharma Global Fze
- Units Affected
- 3263 bottles
- Distribution
- Nationwide.
- Location
- Sharm, N/A
Frequently Asked Questions
What product 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. Recalled by Sun Pharma Global Fze. Units affected: 3263 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: 6 month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 18, 2015. Severity: Moderate. Recall number: D-0386-2015.
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