Drug 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.
D-0610-2016
Product summary
- Event
- Event 73094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,888 cartons
- Official record key
drug-enforcement:D-0610-2016
Official wording
Reason: Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Code information: Lot # 151387, Exp 10/31/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification