FDA Drug recall D-0437-2017
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31
- FDA Drug
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31 by Roxane Laboratories, citing failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0437-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-22 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Roxane Laboratories |
| Distribution | US |
Product
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Reason
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Identifiers
| ndc | 0054-4297-31 |
|---|---|
| ndc | 0054-4297-25 |
| ndc | 0054-8297-25 |
| ndc | 0054-4299-31 |
| ndc | 0054-4299-25 |
| ndc | 0054-8299-25 |
| ndc | 0054-4301-29 |
| ndc | 0054-4301-25 |
| ndc | 0054-8301-25 |
| ndc | 0054-3298-63 |
| ndc | 0054-3294-50 |
| ndc | 0054-3294-46 |
| code_info | Lot# 660833A, Exp 08/31/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0437-2017%22
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