FDAClass IIAugust 25, 2021

GaviLyteTM - C PEG-3350 recall

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873…

Why was GaviLyteTM - C PEG-3350 recalled?

Failed Stability Specification; Out of specification for Osmolarity

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 S001133, exp 7/2022

Product
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873…
Recalling firm
Novel Laboratories, Inc. d.b.a LUPIN
Quantity
20,814 bottles
Distribution
Nationwide
Recall date
August 25, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls