FDA Recall D-1344-2019
SELECT DISTRIBUTIONS LLC · Ferndale, MI
Class I — life-threatening Terminated 1651 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
Recall record
- Recall number
D-1344-2019- 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
- MI, OH
- Recall initiated
- 2019-04-09
- Classified by FDA Center
- 2019-06-13
- FDA published
- 2019-06-19
- Terminated
- 2023-10-16
- Recalling firm
- SELECT DISTRIBUTIONS LLC
- Firm location
- Ferndale, MI