FDA-Drug2016-02-03Class II
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.
Amerisource Health Services
Hazard
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Sold states
Nationwide and Puerto Rico
Affected count
3,888 cartons
Manufactured in
2550 John Glenn Ave, Suite A, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2016Don't want to check this manually?
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