Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bottle sold as single and twin pack
Summary
The FDA issued a Class II for Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bottle sold as single a by The Procter & Gamble Company. Reason: Acidified/Low Acid dietary supplement with no approved process..
Details
Source
Food Recall
External ID
F-1537-2022
Action Date
2022-08-10
Status
Terminated
Category
food
Product Description
Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bottle sold as single and twin pack
Lot/Code Info: Batch Numbers: 10324334R1, 10324334R2, 10324334R3, 10324334R4, 10324334R5, 10324334R6,10534334R1, 10534334R2, 10564334R1, 10564334R2, 10764334R1, 11234334R1, 11234334R2, 11244334R1, 12164334N1, 12164334N2, 12864334N1, 20074334N1, 20074334S1, 20134334N1, 20134334N2, 1032C60401, 1032C60402, 1032C60403, 1053C60401, 1053C60402, 1056C60401, 1056C60402, 1076C60401, 1076C60402, 1076C60403, 1116C60410, 1123C60402, 1123C60404, 1124C60401, 1147C60401, 1216C60404, 1217C60401, 1235C60402, 1251C60403, 1251C60404, 1286C60402, 1286C60403, 1286C60404, 1286C60405, 1301C60403, 2007C60402, 2007C60403, 2007C6041, 2013C60401, 2035C60401, 2035C60402, 2080C60401, 2091C60401, 2096C60401 Lot Numbers: 10324334R1, 10324334R2, 10324334R3, 10324334R4, 10324334R5, 10324334R6, 10534334R1, 10534334R2, 10564334R1, 10564334R2, 10764334R1, 11234334R1, 11234334R2, 11244334R1, 12164334N1, 12164334N2, 12864334N1, 20074334N1, 20074334S1, 20134334N1,, 20134334N2, 1032C60401, 1032C60402, 1032C60403, 1053C60401, 1053C60402, 1056C60401, 1056C60402, 1076C60401, 1076C60402, 1076C60403, 1116C60410, 1123C60402, 1123C60404, 1124C60401, 1147C60401, 1216C60404, 1217C60401, 1235C60402, 1251C60403, 1251C60404, 1286C60402, 1286C60403, 1286C60404, 1286C60405, 1301C60403, 2007C60402, 2007C60403, 2007C6041, 2013C60401, 2035C60401, 2035C60402, 2080C60401, 2091C60401, 2096C60401 Product Number: 80358162,80349921 Item UPC: 80358162,323900040151 Case UPC: 10323900043074,10323900040158 Expiration Dates: 10324334R1 07/31/2022, 10324334R2 07/31/2022, 10324334R3 07/31/2022, 10324334R4 07/31/2022, 10324334R5 07/31/2022, 10324334R6 07/31/2022, 10534334R1 07/31/2022, 10534334R2 07/31/2022, 10564334R1 07/31/2022, 10564334R2 07/31/2022, 10764334R1 08/31/2022, 11234334R1 -10/31/2022 , 11234334R2 10/31/2022, 11244334R1 10/31/2022, 12164334N1 01/31/2023, 12164334N2 01/31/2023, 12864334N1 03/31/2023, 20074334N1 06/30/2023, 20074334S1 06/30/2023 , 20134334N1 06/30/2023, 20134334N2 06/30/2023, 1032C60401 07/31/2022, 1032C60402 07/31/2022, 1032C60403 07/31/2022, 1053C60401 07/31/2022, 1053C60402 07/31/2022, 1056C60401 07/31/2022, 1056C60402 07/31/2022, 1076C60401 08/31/2022, 1076C60402 08/31/2022, 1076C60403 08/31/2022, 1116C60410 09/30/2022, 1123C60402 10/31/2022, 1123C60404 10/31/2022, 1124C60401 10/31/2022, 1147C60401 10/31/2022, 1216C60404 01/31/2023, 1217C60401 01/31/2023, 1235C60402 01/31/2023, 1251C60403 02/28/2023, 1251C60404 02/28/2023, 1286C60402 03/31/2023, 1286C60403 03/31/2023, 1286C60404 03/31/2023, 1286C60405 03/31/2023, 1301C60403 03/31/2023, 2007C60402 - , 2007C60403 06/30/2023, 2007C6041 06/30/2023, 2013C60401 06/30/2023, 2035C60401 07/31/2023, 2035C60402 07/31/2023, 2080C60401 08/31/2023, 2091C60401 09/30/2023, 2096C60401 09/30/2023
Quantity Affected: 90,522 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-1537-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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