FDA Drug recall D-1169-2014
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- FDA Drug
- Class I
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class I recall of Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) by Fabscout Entertainment, citing marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutic….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1169-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-27 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fabscout Entertainment |
| Distribution | US |
Product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Identifiers
| code_info | All lots |
|---|
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-1169-2014%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.