October 2023 FDA Recall Drug by Noah's Wholesale Llc
D-0158-2024 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Noah's Wholesale Llc on October 16, 2023 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Florida, Bahamas, Turks & Caicos Islands and the recall is currently ongoing.

Recall Number: D-0158-2024

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Initiated
10-16-2023
Reported
12-27-2023
Quantity
173 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93231
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Noah's Wholesale LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Bahamas, Turks & Caicos Islands
Product Description About Product Description
Full technical description of the product.
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7

Batch or Lot Expiration Information

Lot# 03032021 Exp: 12/31/2027