D-0386-2015 Class II Terminated
FDA drug recall D-0386-2015 was initiated by Sun Pharma Global Fze on January 21, 2015 and is designated Class II. Reason for recall: Failed Dissolution Specifications: 6 month time point. The recall status is terminated (terminated October 23, 2015). Affected quantity: 3263 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 18, 2015
- Initiation Date
- January 21, 2015
- Termination Date
- October 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3263 bottles
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.
Distribution Pattern
Nationwide.
Code Information
Lot #: JKN0249A Exp 02/2016