Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot: 0546089 Exp. 09/2023
Where it was sold
Product was distributed to one distributor in Texas for further distribution
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0644-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2022
- FDA report date
- Mar 9, 2022
- Quantity
- 11,580 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vi-Jon, Inc.
Original FDA data
Every field from FDA enforcement report D-0644-2022, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 89706
- Address
- 1 Swan Dr
- Code information
- Lot: 0546089 Exp. 09/2023
- Postal code
- 37167-2099
- Report date
- Mar 9, 2022
- Product type
- Drugs
- Recall number
- D-0644-2022
- Classification
- Class II
- Recalling firm
- Vi-Jon, Inc.
- Product quantity
- 11,580 bottles
- Termination date
- Aug 15, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to one distributor in Texas for further distribution
- Recall initiation date
- Mar 2, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2022