Ultra Supplement LLC recalls SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bango…
- Recall date
- July 21, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1350-2022
- FDA classification
- Class I
- Brand / firm
- Ultra Supplement LLC
- Sold / distributed
- Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
Why it was recalled
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
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