Amerisource Health Services recalls Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled
Recalled February 3, 2016 · FDA recall D-0610-2016 · Amerisource Health Services
Hazard
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. · FDA Class II
Units
3,888 cartons
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
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.
Manufacturer(s)
Amerisource Health Services
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →