FDA Drug recall D-341-2014
Bumetanide Tablets USP 0.5 mg
- FDA Drug
- Class III
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class III recall of Bumetanide Tablets USP 0.5 mg by Sandoz, citing failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature condi….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-341-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-06 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
Reason
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Identifiers
| ndc | 0185-0128-05 |
|---|---|
| ndc | 0185-0128-01 |
| ndc | 0185-0129-05 |
| ndc | 0185-0129-01 |
| ndc | 0185-0130-05 |
| ndc | 0185-0130-01 |
| code_info | Lot #: a) CU6131, b) CW1161 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-341-2014%22
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