D-0111-2024 Class II Terminated
FDA drug recall D-0111-2024 was initiated by Integrity Bio-Chemicals LLC on October 18, 2023 and is designated Class II. Reason for recall: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. The recall status is terminated (terminated March 21, 2025). Affected quantity: 1-55 gallon drum.
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2023
- Initiation Date
- October 18, 2023
- Termination Date
- March 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1-55 gallon drum
Product Description
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
Reason for Recall
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Distribution Pattern
Distributed to one distributor in OK with possibility of further distribution
Code Information
Lot #: 2134106, No Exp date, Manufacturing Date: 11/23/21