FDA Recall D-1350-2022
Ultra Supplement LLC · Wilmington, DE
Class I — life-threatening Terminated 452 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Reason for recall
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Recall record
- Recall number
D-1350-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
- Recall initiated
- 2022-07-21
- Classified by FDA Center
- 2022-08-17
- FDA published
- 2022-08-10
- Terminated
- 2023-10-16
- Recalling firm
- Ultra Supplement LLC
- Firm location
- Wilmington, DE