FDAFDA · Food and drugs·Recall number D-0610-2016
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.
Published February 3, 2016 · Recall initiated: January 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot # 151387, Exp 10/31/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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