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Recall Observatory FDA recall evidence

Drug product

UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

D-0166-2025

November 14, 2024

Class II

Product summary

Firm
MXBBB
Event
Event 95777
Status
Ongoing
Classification
Class II
Quantity
321 bottles
Official record key
drug-enforcement:D-0166-2025

Official wording

Reason: 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.

Code information: Lot#: 24183, Exp 07/01/28

Distribution pattern: Product was sold via Amazon Marketplace.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations