Drug & medication recalls Moderate risk

Bit & Bet LLC recalls Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil s…

Recall date
March 24, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0388-2021
FDA classification
Class II
Brand / firm
Bit & Bet LLC
Sold / distributed
Nationwide

Why it was recalled

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.

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