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.
Reported: February 3, 2016 Initiated: January 18, 2016 #D-0610-2016
Product Description
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.
Details
- Recalling Firm
- Amerisource Health Services
- Units Affected
- 3,888 cartons
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product 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.. Recalled by Amerisource Health Services. Units affected: 3,888 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 3, 2016. Severity: Moderate. Recall number: D-0610-2016.
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