FDA Drug Recalls

Recalls / Class II

Class IID-0799-2021

Product

Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049

Brand name
70% Isopropyl Rubbing Alcohol
Generic name
Isopropyl Rubbing Alcohol
Active ingredient
Isopropyl Alcohol
Route
Topical
NDC
30142-810
FDA application
M003
Affected lot / code info
Lot: 0542077 Exp. 07/2023

Why it was recalled

Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% 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

Recalling firm

Firm
Vi-Jon, Inc.
Manufacturer
The Kroger Co.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Swan Dr, N/A, Smyrna, Tennessee 37167-2099

Distribution

Quantity
21,156 bottles
Distribution pattern
Distributed Nationwide in the USA

Timeline

Recall initiated
2021-09-09
FDA classified
2021-09-15
Posted by FDA
2021-09-22
Terminated
2023-06-21
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0799-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.