Why it was recalled
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Product description
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.
Lot numbers, UPCs & expiration codes
Lots: 0001, 0005, 0007
Where it was sold
IA, NE
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-0166-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 6, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Southwest Iowa Renewable Energy LLC
Original FDA data
Every field from FDA enforcement report D-0166-2023, exactly as published.
Show all FDA fields
- City
- Council Bluffs
- State
- IA
- Status
- Ongoing
- Country
- United States
- Event ID
- 90953
- Address
- 10868 189th St
- Code information
- Lots: 0001, 0005, 0007
- Postal code
- 51503-6925
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0166-2023
- Classification
- Class II
- Recalling firm
- Southwest Iowa Renewable Energy LLC
- Product quantity
- a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
- Reason for recall
- CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.
- Distribution pattern
- IA, NE
- Recall initiation date
- Oct 6, 2022
- Initial firm notification
- Telephone
- Center classification date
- Jan 19, 2023