FDA recall D-0610-2016

Product

Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.

Reason for recall

Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-01-18

Report date

2016-02-03

Termination date

2017-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2016