FDA · F-0407-2025 · published 2025-01-15
FDA campaign F-0407-2025
Class IIHazard
Potential for packaging failures that could compromise the sterility of the product, resulting in spoilage.
Distribution
The product was distributed to one Direct Consignee, two locations: AL, AR
REKALLD area-alert coverage: nationwide (our reading of the distribution above)
The text above is quoted verbatim from the FDA record. Confirm the affected units and the remedy with the manufacturer or FDA. Recall data may be incomplete, delayed, or superseded.
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