FDA recall D-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

Reason for recall

Failed Dissolution Specifications: 6 month time point.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2015-01-21

Report date

2015-02-18

Termination date

2015-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sharm, N/A, United Arab Emirates

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2015