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
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
CGMP Deviations