FDA Recall D-0220-2017
Making It a Lifestyle · Corpus Christi, TX
Class I — life-threatening Terminated 1615 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Reason for recall
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Recall record
- Recall number
D-0220-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2016-04-29
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2020-09-30
- Recalling firm
- Making It a Lifestyle
- Firm location
- Corpus Christi, TX