Vicks Children's Botanicals Liquid Nighttime 4oz plastic bottle
Summary
The FDA issued a Class II for Vicks Children's Botanicals Liquid Nighttime 4oz plastic bottle by The Procter & Gamble Company. Reason: Acidified/Low Acid dietary supplement with no approved process..
Details
Source
Food Recall
External ID
F-1535-2022
Action Date
2022-08-10
Status
Terminated
Category
food
Product Description
Vicks Children's Botanicals Liquid Nighttime 4oz plastic bottle
Lot/Code Info: Batch Numbers: 0240C60404, 1166C60401, 1218C60401, 1237C60401, 1321C60401,1321C60402, 1321C604Q1, 2038C60401, 2152C60401 , 2153C60401 Lot Numbers: 0240C60404, 1166C60401, 1218C60401, 1237C60401, 1321C60401, 1321C60402, 1321C604Q1, 2038C60401, 2152C60401, 2153C60401 Product Number: 80338364 Item UPC: 323900041066 Case UPC: 10323900041063 Expiration Dates: 0240C60404 07/31/2022, 1166C60401 05/31/2023, 1218C60401 07/31/2023, 1237C60401 07/31/2023, 1321C60401 10/31/2023, 1321C60402 10/31/2023, 1321C604Q1 10/31/2023, 2038C60401 01/31/2024, 2152C60401 05/31/2024, 2153C60401 05/31/2024
Quantity Affected: 18,490 cases
Reason for Recall
Acidified/Low Acid dietary supplement with no approved process.
Distribution
Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-12
Company
Cincinnati, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 30 food recalls issued in the same week, part of 204 food-related FDA actions this month.
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Procter & Gamble Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Procter & Gamble Company have FDA actions?
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1535-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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