Drug Enforcement D-0166-2025

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.

Status

Ongoing

Classification

Class II

Report Date

January 1, 2025

Termination Date

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Product Information

Product description
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Product quantity
321 bottles
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.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Product was sold via Amazon Marketplace.

Location & Firm

Recalling firm
MXBBB
Address
1162 Tio Dink Cir

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0166-2025
Event ID
95777
Recall initiation date
November 14, 2024
Center classification date
December 26, 2024
Code info
Lot#: 24183, Exp 07/01/28
More code info
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