Class IICompleted
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gall… recall
FDA recall D-0640-2024 · initiated Aug 5, 2024
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Aug 28, 2024How we research
Zeco LLC recalled HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.7… in Aug 2024 — an FDA Class II recall (D-0640-2024) because CGMP Deviations: sterile water not used for production.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: sterile water not used for production
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Lot #: a) 41320, Exp. Date 7/27/2024; 41020, Exp. Date 8/9/2024; BC06614, Exp. Date 8/15/2024; BCT07768, Exp. Date 9/23/2024; BCT09410, Exp. Date 11/17/2024; CCT02139, Exp. Date 3/10/2025; CCT01561, Exp. Date 3/15/2025; CCT02953, Exp. Date 4/10/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT04010, Exp. Date 5/17/2025; CCT07274, Exp. Date 8/24/2025; CCT09516, Exp. Date 11/1/2025; CCT10500, Exp. Date 12/5/2025; DCT01157, Exp. Date 2/1/2026; DCT01586, Exp. Date 2/14/2026; DCT03947, Exp. Date 4/30/2026; DCT04406, Exp. Date 5/24/2026; CCT01651, Exp. Date 2/21/2025 b) CCT03654, Exp. Date 5/11/2025 c) BCT07768, Exp. Date 9/23/2024; BCT07975, Exp. Date 9/29/2024; BCT09410, Exp. Date 11/17/2024; BCT10246, Exp. Date 12/20/2024; CCT00705, Exp. Date 1/23/2025; CCT01952, Exp. Date 3/3/2025; CCT02139, Exp. Date 3/10/2025; CCT02689, Exp. Date 3/30/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT04010, Exp. Date 5/17/2025; CCT04630, Exp. Date 6/6/2025; CCT05946, Exp. Date 7/17/2025; CCT06785, Exp. Date 8/10/2025; CCT07274, Exp. Date 8/24/2025; CCT08515, Exp. Date 10/2/2025; CCT08936, Exp. Date 10/13/2025; CCT09516, Exp. Date 11/1/2025; CCT10888, Exp. Date 12/18/2025; DCT01157, Exp. Date 2/1/2026; DCT01586, Exp. Date 2/14/2026; DCT02902, Exp. Date 3/27/2026; DCT03947, Exp. Date 4/30/2026; CCT01952, Exp. Date 3/3/2025; d) BC06614, Exp. Date 8/15/2024; CCT00705, Exp. Date 1/23/2025; CCT06785, Exp. Date 8/10/2025; CCT10500, Exp. Date 12/5/2025; DCT01586, Exp. Date 2/14/2026
Details
- Product
- HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210
- Recalling company
- Zeco LLC
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
- Initiated
- Aug 5, 2024
- FDA report date
- Aug 28, 2024
Frequently asked
- Was HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.7… recalled?
- Zeco LLC recalled HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.7… in Aug 2024 — an FDA Class II recall (D-0640-2024) because CGMP Deviations: sterile water not used for production. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.7… recalled?
- Per the FDA enforcement record, the reason for recall D-0640-2024 was: CGMP Deviations: sterile water not used for production
- Is a recalled HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.7… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.7… are affected?
- Distributed: Nationwide within the United States and Toronto, Canada (Rubbing alcohol). The recall covers these lots — Lot #: a) 41320, Exp. Date 7/27/2024; 41020, Exp. Date 8/9/2024; BC06614, Exp. Date 8/15/2024; BCT07768, Exp. Date 9/23/2024; BCT09410, Exp. Date 11/17/2024; CCT02139, Exp. Date 3/10/2025; CCT01561, Exp. Date 3/15/2025; CCT02953, Exp. Date 4/10/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT0401…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0640-2024.