Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
Reason cGMP deviations
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml)…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
What was recalled
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
- Recalling firm
- Homeocare Laboratories, Inc.
- NDC code
- 69685-143-16
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0610-2024
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.
Other Peppermint recalls
See all
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC…
Reason cGMP deviations
Class II · Moderate risk Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH…
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ…
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Ongoing
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
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