FDAClass IIMay 25, 2022

GaviLyte -C recall

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

Why was GaviLyte -C recalled?

Failed Stability Specification

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?

Lot # S001132, exp. date July 2022 NDC # 43386-060-19

Product
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
26,910 bottles
Distribution
Product was distributed nationwide, including Puerto Rico.
Recall date
May 25, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls