Class II
Terminated
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.
This recall has been terminated (originally issued February 3, 2016).
- Company
- Amerisource Health Services
- Recall Initiated
- January 18, 2016
- Posted
- February 3, 2016
- Recall Number
- D-0610-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,888 cartons
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot # 151387, Exp 10/31/16
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