Why it was recalled
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Product description
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
Lot numbers, UPCs & expiration codes
Lot #: 2133608, No exp Date. Manufacturing Date: 11/23/21
Where it was sold
Distributed to one distributor in OK with possibility of further distribution
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-0110-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 18, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 1 55-gallon drum
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Integrity Bio-Chemicals LLC
Original FDA data
Every field from FDA enforcement report D-0110-2024, exactly as published.
Show all FDA fields
- City
- Cresson
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 93199
- Address
- 1100 N Cresson Hwy
- Code information
- Lot #: 2133608, No exp Date. Manufacturing Date: 11/23/21
- Postal code
- 76035-4121
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0110-2024
- Classification
- Class II
- Recalling firm
- Integrity Bio-Chemicals LLC
- Product quantity
- 1 55-gallon drum
- Termination date
- Mar 21, 2025
- Reason for recall
- CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
- Distribution pattern
- Distributed to one distributor in OK with possibility of further distribution
- Recall initiation date
- Oct 18, 2023
- Initial firm notification
- Center classification date
- Nov 20, 2023