Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 4...

FDA Drug Recall #D-1061-2019 — Class II — February 6, 2019

Recall Summary

Recall Number D-1061-2019
Classification Class II — Moderate risk
Date Initiated February 6, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ecolab Inc
Location Saint Paul, MN
Product Type Drugs
Quantity a) 118 units, b) 3,783 units

Product Description

Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.

Reason for Recall

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Distribution Pattern

Nationwide within the United States

Lot / Code Information

Lot #: a) HS092781, Exp. SEP 2020; b) HS091381, HS091781, and HS091881, Exp. SEP 2020

Other Recalls from Ecolab Inc

Recall # Classification Product Date
D-1539-2020 Class II Hand Sanitizer (Alcohol 80% v/v) topical soluti... Jul 30, 2020
D-1393-2019 Class III QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Et... May 10, 2019
D-1064-2019 Class II Express Gel Hand Sanitizer (Ethyl Alcohol 70%),... Feb 6, 2019
D-1062-2019 Class II Moisturizing Gel Hand Sanitizer (Ethyl Alcohol ... Feb 6, 2019
D-1063-2019 Class II Quick-Care Foam Hand Sanitizer (Ethyl alcohol 6... Feb 6, 2019

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.