Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordyceps Sinensis, Go Ji Extract, Superoxide Dismutase).
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
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