Multi-event August 2024 FDA Recall Drug by Zeco Llc

This Multi-event Class II drug recall was voluntarily initiated by Zeco Llc on August 5, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently completed.

Reported Recall Events

D-0640-2024 COMPLETED D-0639-2024 COMPLETED

Recall Number: D-0640-2024

Reason for Recall
CGMP Deviations: sterile water not used for production
Initiated
08-05-2024
Reported
08-28-2024
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95067
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zeco LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-0639-2024

Reason for Recall
CGMP Deviations: sterile water not used for production
Initiated
08-05-2024
Reported
08-28-2024
Quantity
604

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95067
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zeco LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
Product Description About Product Description
Full technical description of the product.
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.

Batch or Lot Expiration Information

Lot# : a) BC05977, Exp. Date 08/05/2024; B06664, Exp. Date 08/17/2024, B06664, Exp. Date 08/17/2024; b) B06664, Exp. Date 08/17/2024; BC06867, Exp. Date 10/03/2024; BC06867, Exp. Date 10/03/2024; BCT08309, Exp. Date 10/11/2024; BK06696, Exp. Date 08/17/2024; CCT01774, Exp. Date 02/24/2025; CCT03579, Exp. Date 05/01/2025; CKM06510, Exp. Date 08/02/2025; DCT04332, Exp. Date 05/17/2026