Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC…
Reason LABELING: LABEL MIX-UP.
Class I — High risk. Reasonable probability of serious harm or death.
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
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.
Reason Discoloration
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Reason Labeling mix-up - Indications on product label are incorrect.
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