Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 pac...

FDA Drug Recall #D-1574-2020 — Class I — August 14, 2020

Recall Summary

Recall Number D-1574-2020
Classification Class I — Serious risk
Date Initiated August 14, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SG24 LLC
Location Bolingbroke, GA
Product Type Drugs
Quantity 122,500 individual wipe packets

Product Description

Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004

Reason for Recall

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Distribution Pattern

Nationwide

Lot / Code Information

SKU 03150025 All lots labeled to contain methanol

Other Recalls from SG24 LLC

Recall # Classification Product Date
D-1572-2020 Class I SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottl... Aug 14, 2020
D-1573-2020 Class I Skin Guard 24 All-Day Hand Sanitizer 10 mL Pock... Aug 14, 2020
D-1571-2020 Class I SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bo... Aug 14, 2020

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

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.