Drug Enforcement D-0639-2024

CGMP Deviations: sterile water not used for production

Status

Ongoing

Classification

Class II

Report Date

August 28, 2024

Termination Date

Product Information

Product description
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.
Product quantity
604
Reason for recall
CGMP Deviations: sterile water not used for production
Recall initiation reason
Initial firm notification
Distribution pattern
Nationwide within the United States and Toronto, Canada (Rubbing alcohol)

Location & Firm

Recalling firm
Zeco LLC
Address
3401 Cummings Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0639-2024
Event ID
95067
Recall initiation date
August 5, 2024
Center classification date
August 20, 2024
Code info
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
More code info