FDA Drug recall D-1601-2014
Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
- FDA Drug
- Class I
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class I recall of Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789 by Nova Products, citing marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain u….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1601-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-28 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nova Products |
| Distribution | US |
Product
Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
Reason
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Identifiers
| code_info | Lot# 13071012 |
|---|
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-1601-2014%22
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