November 2024 FDA Recall Drug by Mxbbb
D-0166-2025 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Mxbbb on November 14, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was sold via Amazon Marketplace. and the recall is currently ongoing.

Recall Number: D-0166-2025

Reason for Recall
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Initiated
11-14-2024
Reported
01-01-2025
Quantity
321 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95777
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MXBBB
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was sold via Amazon Marketplace.
Product Description About Product Description
Full technical description of the product.
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

Batch or Lot Expiration Information

Lot# : 24183, Exp 07/01/28