Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
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 Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Reason cGMP deviations
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
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