FDA Recall D-1037-2020
Med Man Distribution, Inc.
Class I — life-threatening Terminated 1439 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783
Reason for recall
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Recall record
- Recall number
D-1037-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2019-11-08
- Classified by FDA Center
- 2020-03-19
- FDA published
- 2020-03-25
- Terminated
- 2023-10-17
- Recalling firm
- Med Man Distribution, Inc.