FDAClass IIJune 2, 2021

Polyethylene Glycol 3350 Powder for Solution recall: CGMP Deviations

Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010

Why was Polyethylene Glycol 3350 Powder for Solution recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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?

All Lots distributed 02/23/2021 through 03/10/2021.

Product
Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010
Recalling firm
Cardinal Health Inc.
Quantity
163 bottles
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls