BEUDAMED
    FDA Enforcement Class II Terminated

    First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)

    Recall: Z-1031-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-1031-2022
    Event ID
    89824
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ASO LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2022
    Initiation Date
    March 2, 2022
    Classification Date
    May 4, 2022
    Termination Date
    June 12, 2024
    Address
    300 Sarasota Center Blvd, N/A, Sarasota, FL, 34240-9381, United States

    Description

    First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)

    Reason

    Kits contained recalled acetaminophen.

    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).

    Distribution

    US Nationwide distribution.

    Quantity

    73,668 kits