Why it was recalled
CGMP deviations
Product description
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Lot numbers, UPCs & expiration codes
Lot #: 042224-L1, Exp. Date 04/22/2025
Where it was sold
Product was sent to one distributor in North Carolina.
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-0667-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 18, 2024
- FDA report date
- Oct 2, 2024
- Quantity
- 120 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EnviroServe Chemicals Inc.
Original FDA data
Every field from FDA enforcement report D-0667-2024, exactly as published.
Show all FDA fields
- City
- Dunn
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 95390
- Address
- 603 S Wilson Ave
- Code information
- Lot #: 042224-L1, Exp. Date 04/22/2025
- Postal code
- 28334-5832
- Report date
- Oct 2, 2024
- Product type
- Drugs
- Recall number
- D-0667-2024
- Classification
- Class II
- Recalling firm
- EnviroServe Chemicals Inc.
- Product quantity
- 120 bottles
- Reason for recall
- CGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
- Distribution pattern
- Product was sent to one distributor in North Carolina.
- Recall initiation date
- Sep 18, 2024
- Center classification date
- Sep 24, 2024