FDA Recall D-0101-2017
SOS Telecom Inc. · Bayside, NY
Class I — life-threatening Terminated 785 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Reason for recall
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Recall record
- Recall number
D-0101-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- NY
- Recall initiated
- 2016-05-12
- Classified by FDA Center
- 2016-10-14
- FDA published
- 2016-10-26
- Terminated
- 2018-07-06
- Recalling firm
- SOS Telecom Inc.
- Firm location
- Bayside, NY