Why it was recalled
cGMP deviations
Product description
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
Lot numbers, UPCs & expiration codes
Lot # 2357B,2333, exp. date Sep-2; 2367C, 2367D, exp. date Nov-23; 2367E, 2367F, exp. date Jan-24; 2395A, 2406, exp. date Feb-2; 2395B, exp. date Mar-24; 2395C, exp. date Apr-24
Where it was sold
Product was distributed USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0886-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2023
- FDA report date
- Jul 5, 2023
- Quantity
- 130,762/16 oz. tottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Homeocare Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0886-2023, exactly as published.
Show all FDA fields
- City
- Yonkers
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 92453
- Address
- 7 Odell Plz Ste 142-146
- Code information
- Lot # 2357B,2333, exp. date Sep-2; 2367C, 2367D, exp. date Nov-23; 2367E, 2367F, exp. date Jan-24; 2395A, 2406, exp. date Feb-2; 2395B, exp. date Mar-24; 2395C, exp. date Apr-24
- Postal code
- 10701-1407
- Report date
- Jul 5, 2023
- Product type
- Drugs
- Recall number
- D-0886-2023
- Classification
- Class II
- Recalling firm
- Homeocare Laboratories, Inc.
- Product quantity
- 130,762/16 oz. tottles
- Termination date
- Sep 16, 2024
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
- Distribution pattern
- Product was distributed USA nationwide.
- Recall initiation date
- Jun 5, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2023