Drug recall: Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
FDA enforcement event 65892 is a drug recall by Fabscout Entertainment, Inc of Ft Lauderdale, FL, initiated 27 Jun 2013 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 18% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 2 Oct 2019. Initiation: voluntary: firm initiated. Fabscout Entertainment, Inc has 2 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fabscout Entertainment, Inc, Ft Lauderdale, FL.
Reason for recall
"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."
Distribution
"Nationwide and France"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1169-2014 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | — | Class I | Terminated | 26 Mar 2014 |
| D-1170-2014 | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language) | — | Class I | Terminated | 26 Mar 2014 |
Context
Other enforcement events for Fabscout Entertainment, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Aug 2013 | Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No | Drug | Class I | 3 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and France"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Oct 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.