July 2024 FDA Recall Drug by Main Products Inc
D-0626-2024 - Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

This Class I drug recall was voluntarily initiated by Main Products Inc on July 18, 2024 for the product Drug. The FDA reported the reason for recall as marketed without approved nda/anda. fda analysis found product to be tainted with undeclared diclofenac and omeprazole.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0626-2024

Reason for Recall
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Initiated
07-18-2024
Reported
08-14-2024
Quantity
57, 340 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94962
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.
MAIN PRODUCTS INC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the U.S
Product Description About Product Description
Full technical description of the product.
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

Batch or Lot Expiration Information

Lot# All lots within expiry