FDAClass IIMarch 2, 2022

Infant's Grape Flavored Acetaminophen Oral Suspension recall: CGMP Deviations

Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16

Why was Infant's Grape Flavored Acetaminophen Oral Suspension recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch: 1CK1276, 1FK1184, 1GK0821 and 1EK1046, Exp 02/28/2023

Product
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16
Recalling firm
Perrigo Company PLC
Quantity
37,152 bottles
Distribution
Nationwide in the USA
Recall date
March 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls