FDA Drug Recalls

Recalls / Class II

Class IID-1191-2022

Product

Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 59779-871-45, UPC 0-50428-40950-3

Brand name
Hydrogen Peroxide
Generic name
Hydrogen Peroxide
Active ingredient
Hydrogen Peroxide
Route
Topical
NDC
59779-871
FDA application
M003
Affected lot / code info
Lot: 0562272, Exp 02/2025

Why it was recalled

Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.

Recalling firm

Firm
Vi-Jon, LLC
Manufacturer
CVS Pharmacy, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Swan Dr, Smyrna, Tennessee 37167-2099

Distribution

Quantity
36,840 bottles
Distribution pattern
USA Nationwide

Timeline

Recall initiated
2022-06-24
FDA classified
2022-07-14
Posted by FDA
2022-07-20
Terminated
2024-06-17
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1191-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.