FDA Drug recall D-1082-2015
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc
- FDA Drug
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc by Alvogen, citing failed Dissolution Specification; 6 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1082-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-21 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alvogen |
| Distribution | US |
Product
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Reason
Failed Dissolution Specification; 6 month time point
Identifiers
| ndc | 47781-303-01 |
|---|---|
| code_info | Lot 457529, exp. 08/2016 |
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-1082-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.