Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and...

FDA Drug Recall #D-1503-2020 — Class I — July 1, 2020

Recall Summary

Recall Number D-1503-2020
Classification Class I — Serious risk
Date Initiated July 1, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Spartan Chemical Co Inc
Location Maumee, OH
Product Type Drugs
Quantity a) 60,796 cartridges, b) 420 gallon containers

Product Description

Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.

Reason for Recall

Microbial contamination of non-sterile products: positive microbial contamination in product.

Distribution Pattern

Nationwide USA, Panama, St. Maarten

Lot / Code Information

a) 42.27 oz cartridge: 518491, 518492, 518498, 518499, 518500, 520057, 520058, 520060, 520061; b) 1 gallon container: 520032, Exp. 06/30/2022.

Other Recalls from Spartan Chemical Co Inc

Recall # Classification Product Date
D-0360-2021 Class II foamyiQ Lemon Blossom Hand Sanitizer (benzalkon... Mar 29, 2021
D-0362-2021 Class II Lite'n Foamy E2 Sanitizing Handwash (Benzalkoni... Mar 29, 2021
D-0364-2021 Class II Lite'n Foamy Healthcare Personnel Handwash (Chl... Mar 29, 2021
D-0361-2021 Class II Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), ... Mar 29, 2021
D-0359-2021 Class I Lite'n Foamy Lemon Blossom Hand Sanitizer (benz... Mar 29, 2021

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.