The Recall Desk
HighFDA (Drugs)·D-0639-2024·Announced 2024-08-28

Rubbing Alcohol Recalled for Non-Sterile Water in Manufacturing

ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall addresses a CGMP deviation involving non-sterile water in topical antiseptic production, representing a risk-of-harm situation. No illnesses or injuries have been reported in the source text, which per the rubric keeps the severity at 'High' rather than 'Severe.'

Plain-English summary

ZEE Company is recalling Rubbing Alcohol (70% Isopropyl Alcohol), a first-aid antiseptic, packaged in 1-gallon jugs and 55-gallon drums. The recall affects 604 units manufactured by Zeco LLC and sold by ZEE Company, a member of the Vincit Group.

The product was manufactured using non-sterile water instead of sterile water, violating Current Good Manufacturing Practices (CGMP). Non-sterile water used in the production of a topical antiseptic could potentially compromise the product's effectiveness and introduce unwanted contaminants.

The affected product was distributed nationwide in the United States and in Toronto, Canada. Specific lot numbers and expiration dates are identified in the official FDA recall.

The recalled product

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.
Manufacturer
Zeco LLC
Category
Drug — First-Aid Antiseptic
Hazard
  • cgmp-deviation
  • sterility-violation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • Lot #: a) BC05977
  • Exp. Date 08/05/2024
  • B06664
  • Exp. Date 08/17/2024
  • b) B06664
  • BC06867
  • Exp. Date 10/03/2024
  • BCT08309
  • Exp. Date 10/11/2024
  • BK06696
  • 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

Distributed nationwide across the United States.

Related recalls

Same category