Levofloxacin Tablets USP — Class II drug recall D-0610-2016
Terminated recall by Amerisource Health Services, reported 2016-02-03, distributed nationwide. Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
| Recall number | D-0610-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services, Columbus, OH, United States |
| Recall initiated | 2016-01-18 |
| Classified | 2016-01-27 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2017-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,888 cartons |
| Reason classes | specification failure |
| NDC | 68084-0482-01 |
| Lot numbers | 151387 |
| Expiration dates | 2016-10-31 |
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.
Reason for recall
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0610-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.