Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1031-2022Class II

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

Aso LLC / initiated 2022-03-02 / Terminated / root cause: manufacturing process

ASO LLC began a recall of First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon) on . FDA classified it as Class II and gives the reason as "Kits contained recalled acetaminophen". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1031-2022
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Aso LLC
Product
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
Product code
LRR First Aid Kit With Drug
Reason for recall
Kits contained recalled acetaminophen.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
Action
A customer letter dated 03/02/2022 was issued to consignees notifying them of the recall. Consignees are asked to contact the recalling firm to facilitate return of the product. A customer response form is included that must be completed and returned to the recalling firm. If the customers have any inventory of the expired products, they may send Collect via YRC Freight Service back to ASO, LLC in Sarasota, FL.
Quantity in commerce
73,668 kits
Distribution
US Nationwide distribution.
Product codes and lots
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).

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1031-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1031-2022Class IITerminatedVoluntary: Firm initiated