HAND-I-SAN recalled over manufacturing violations

Recall date

August 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zeco LLC recalls HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4…

Recall number

D-0640-2024

FDA classification

Class II

Brand / firm

Zeco LLC

Sold / distributed

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

Why it was recalled

CGMP Deviations: sterile water not used for production

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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