D-0166-2025 Class II Ongoing
FDA drug recall D-0166-2025 was initiated by MXBBB on November 14, 2024 and is designated Class II. 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 confirmi… The recall status is ongoing. Affected quantity: 321 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2025
- Initiation Date
- November 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 321 bottles
Product Description
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
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.
Distribution Pattern
Product was sold via Amazon Marketplace.
Code Information
Lot#: 24183, Exp 07/01/28