Gavilyte-N recall: Labeling Error
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc.…
Why was Gavilyte-N recalled?
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
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 #: a) S800021, Exp 30-Nov-20; b) S800175, Exp 31-Dec-20; c) S 800401, Exp 28-Feb-21; S800426, Exp 31-Mar-21; S800920, Exp 31-Aug-21.
- Product
- Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc.…
- Recalling firm
- LUPIN SOMERSET
- Quantity
- 76422 bottles
- Distribution
- Nationwide
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)