FDA Recall D-1292-2019
D.B.P. Distribution · Chatsworth, CA
Class I — life-threatening Terminated 1414 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
Reason for recall
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Recall record
- Recall number
D-1292-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide.
- Recall initiated
- 2019-04-23
- Classified by FDA Center
- 2019-05-22
- FDA published
- 2019-05-22
- Terminated
- 2023-03-07
- Recalling firm
- D.B.P. Distribution
- Firm location
- Chatsworth, CA