Recalls / Class II
Class IID-0597-2022
Product
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
- Brand name
- Parents Choice Infants Pain And Fever
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 49035-766
- FDA application
- M013
- Affected lot / code info
- Batch: 1CK1274, Exp 02/28/2023
Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm
- Firm
- Perrigo Company PLC
- Manufacturer
- Wal-Mart Stores Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 55,656 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-10-26
- FDA classified
- 2022-02-23
- Posted by FDA
- 2022-03-02
- Terminated
- 2023-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0597-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.