First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
Summary
The FDA issued a Class II for First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meij by ASO LLC. Reason: Kits contained recalled acetaminophen..
Details
Source
Device Recall
External ID
Z-1031-2022
Action Date
2022-05-11
Status
Terminated
Category
device
Product Description
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
Lot/Code Info: Product distributed in first kits under the following names/codes: 1) Equate (Walmart) - FIRST AID KIT 140 PIECES, SKU #s 566904301 and 567925067 - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item Nos: a) 187619: Lots 00106279 (EXP 4/1/2021); 00106525 (EXP 6/1/2020); 00106615 (EXP 3/1/2021); 00108538 (EXP 3/1/2021); 19252 (EXP.9/1/2021); and 19253 (EXP.9/1/2021) b) 188583: Lots 00106926 (EXP 6/1/2020); 00107119 (EXP 3/1/2021); 00108453 (EXP 3/1/2021); 00106615 (EXP 3/1/2021), and 00108538 (EXP 3/1/2021). 2) Meijer - FIRST AID KIT 150 PIECES, SKU #4212608-024-002 - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item No. 189099, Lot #00107831 (EXP 10/01/2020) 3) Care Science (Amazon) - FIRST AID KIT 200 PIECES, SKU #B07CQBNWQY - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item No. #188819, Lot #00112542 (EXP 06/01/2021).
Quantity Affected: 73,668 kits
Reason for Recall
Kits contained recalled acetaminophen.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-02
Company
Sarasota, FL
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 121 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ASO LLC has 3 FDA actions in our database, including 3 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 (ASO LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ASO LLC have FDA actions?
ASO LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1031-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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