March 2021 FDA Recall Drug by Bit & Bet Llc
D-0388-2021 - Marketed without Approved NDA/ANDA
This Class II drug recall was voluntarily initiated by Bit & Bet Llc on March 24, 2021 for the product Drug. The FDA reported the reason for recall as marketed without approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0388-2021
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
03-24-2021
05-26-2021
3894 ten-count boxes (38,940 capsules)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bit & Bet LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-16-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# All lots within expiry.
