Drug recall: Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive…
Class II FDA enforcement event 90509. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Vi-Jon, LLC started this drug recall on 24 Jun 2022. The firm address in the FDA record is in Smyrna, TN. FDA put the recall in Class II. FDA event 90509 has 1 product record. The first FDA enforcement report date is 20 Jul 2022. The record gives the status Terminated, with the termination date 17 Jun 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
USA Nationwide
Recalling firm
Vi-Jon, LLC, Smyrna, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1191-2022 | 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 | 36,840 bottles | Class II | Terminated | 20 Jul 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2022
- 325
- Share of these events in Class II
- 65%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Sep 2023 | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate | Drug | Class III | 1 |
| 15 Jul 2022 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 | Drug | Class I | 14 |
| 28 Jun 2022 | Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-4 | Drug | Class II | 1 |
| 15 Jun 2022 | 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medli | Drug | Class II | 1 |
| 13 Jun 2022 | CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: C | Drug | Class I | 1 |
| 5 May 2022 | Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouth | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-1191-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90509. https://recallregister.com/fda/ii/90509/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA Nationwide
- What quantity of product is in FDA event 90509?
- The FDA record gives this quantity:
36,840 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2022 have the same class?
- 65% of the 325 drug events that started in 2022 are in Class II.