HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles...
FDA Drug Recall #D-0644-2022 — Class II — March 2, 2022
Recall Summary
| Recall Number | D-0644-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 2, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vi-Jon, Inc. |
| Location | Smyrna, TN |
| Product Type | Drugs |
| Quantity | 11,580 bottles |
Product Description
HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7
Reason for Recall
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Distribution Pattern
Product was distributed to one distributor in Texas for further distribution
Lot / Code Information
Lot: 0546089 Exp. 09/2023
Other Recalls from Vi-Jon, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0799-2021 | Class II | Kroger 70% Isopropyl Alcohol First Aid Antisept... | Sep 9, 2021 |
| D-0520-2019 | Class II | Topical Solution USP Hydrogen Peroxide First Ai... | Feb 20, 2019 |
| D-0006-2018 | Class III | Magnesium Citrate Oral Solution Cherry Flavor, ... | Sep 13, 2017 |
| D-0073-2018 | Class III | Equate Beauty Clarifying Face Daily Moisturizer... | Sep 13, 2017 |
| D-0005-2018 | Class III | Magnesium Citrate Oral Solution Lemon Flavor, 1... | Sep 13, 2017 |
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.