Amerisource Health Services recalls Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled…
- Recall date
- January 18, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0610-2016
- FDA classification
- Class II
- Brand / firm
- Amerisource Health Services
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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