Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-0639-2024

August 05, 2024

Class II

Product summary

Firm
Zeco LLC
Event
Event 95067
Status
Completed
Classification
Class II
Quantity
604
Official record key
drug-enforcement:D-0639-2024

Official wording

Reason: CGMP Deviations: sterile water not used for production

Code 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

Distribution pattern: Nationwide within the United States and Toronto, Canada (Rubbing alcohol)

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations