Recalls / Class II
Class IID-0610-2016
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.
- Affected lot / code info
- Lot # 151387, Exp 10/31/16
Why it was recalled
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 3,888 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-01-18
- FDA classified
- 2016-01-27
- Posted by FDA
- 2016-02-03
- Terminated
- 2017-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0610-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.