Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles recall — FDA D-0584-2026
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
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Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Presence of foreign substance: small metallic particles in chewable tablets.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Contains statement does not declare Almond
Contains statement does not declare Walnut
Product is potentially contaminated with foreign material (plastic particles).
Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
Possible contamination with Cereulide toxin.
Undeclared egg
Contains statement does not declare Crab
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
Contains statement does not declare Hazelnut
Contains statement does not declare Crab and Pollock
Contains statement does not declare Salmon
Potential contamination with foreign objects (metal pieces).
Potential contamination with Salmonella
The product may contain undeclared allergens (cashews, pistachios), and dried cherries.
Potential contamination with foreign objects (metal pieces).
Contains statement does not declare Shrimp
Contains statement does not declare Tuna
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