Class I — High risk. Reasonable probability of serious harm or death.
Microbial contamination
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
Dr. King's Natural Medicine Homeopathic Caffeine Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955540229, NDC 57955-6202-2
Compare with the code on your package — it is the most precise check available.
Drug: Caffeine
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
CGMP Deviations
CGMP Deviations
CGMP Deviations
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
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