Recalls / Class II
Class IID-0386-2015
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
- Affected lot / code info
- Lot #: JKN0249A Exp 02/2016
Why it was recalled
Failed Dissolution Specifications: 6 month time point.
Recalling firm
- Firm
- Sun Pharma Global Fze
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Office # 43 Block Y Saif Zone, N/A, Sharm, N/A N/A, United Arab Emirates
Distribution
- Quantity
- 3263 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2015-01-21
- FDA classified
- 2015-02-12
- Posted by FDA
- 2015-02-18
- Terminated
- 2015-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0386-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.