Recalls / Class II
Class IID-0588-2022
Product
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26
- Brand name
- Childrens Pain And Fever
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 30142-818
- FDA application
- M013
- Affected lot / code info
- Batch: 1BK1045, Exp 12/31/2022
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
- Kroger Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 20,448 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-0588-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.