PlainRecalls
FDA Drug Moderate Class II Terminated

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16

Reported: March 2, 2022 Initiated: October 26, 2021 #D-0584-2022

Product Description

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16

Reason for Recall

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Details

Recalling Firm
Perrigo Company PLC
Units Affected
22,140 bottles
Distribution
Nationwide in the USA
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16. Recalled by Perrigo Company PLC. Units affected: 22,140 bottles.
Why was this product recalled?
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 2, 2022. Severity: Moderate. Recall number: D-0584-2022.