Recalls / Class II
Class IID-0601-2022
Product
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26
- Brand name
- Up And Up Childrens Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 11673-105
- FDA application
- M013
- Affected lot / code info
- Batch: 1CK0998, Exp 01/31/2023
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
- Target Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 4,992 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-0601-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.