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.
Recall initiated: 20160118
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated