Medications & Supplements/Prescription Drugs

LUPIN SOMERSET: Gavilyte-N Oral Solution Recalled Due to Mislabeled Flavor Packets

Agency Publication Date: April 9, 2019

Summary

Lupin Somerset is recalling 76,422 bottles of Gavilyte-N (PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride) for Oral Solution. The orange and cherry flavor packets included with the medication incorrectly list "natural lemon flavor" as an ingredient on their individual labels. This labeling error may cause confusion regarding the actual contents of the flavor packets provided with this prescription bowel prep kit.

Risk

The incorrect ingredient list on the flavor packets could lead patients to believe they are consuming a different flavor or ingredient than intended, though the primary medication itself is not affected. Patients should contact their healthcare provider or pharmacist for guidance regarding the use of these packets.

What You Should Do

Identify if you have Gavilyte-N Oral Solution by checking the bottle for NDC 43386-050-19 and UPC 343386050192.
Check the flavor packets and lot numbers on your packaging to see if they match the following: Lemon Flavor Pack (UPC 343386200023, Lot S800021, Exp 30-Nov-20); Orange Flavor Pack (UPC 343386202027, Lot S800175, Exp 31-Dec-20); or Cherry Flavor Pack (UPC 3433862034, Lots S800401, S800426, or S800920 with Expiration dates through 31-Aug-21).
Contact your healthcare provider or pharmacist for guidance if you have an affected kit, especially if you have sensitivities to specific flavorings.
Return any unused product to the pharmacy for a refund and contact the manufacturer, Lupin Somerset, at their New Jersey location (400 Campus Dr, Somerset, NJ) for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution

Model:

NDC 43386-050-19

UPC Codes:

343386050192

Lot Numbers:

S800021 (Exp 30-Nov-20)

S800175 (Exp 31-Dec-20)

S800401 (Exp 28-Feb-21)

S800426 (Exp 31-Mar-21)

S800920 (Exp 31-Aug-21)

Date Ranges: Expiration dates: 30-Nov-20, 31-Dec-20, 28-Feb-21, 31-Mar-21, 31-Aug-21

Product: Lemon Flavor Pack (2 g)

UPC Codes:

343386200023

Lot Numbers:

S800021 (Exp 30-Nov-20)

Date Ranges: 30-Nov-20

Product: Orange Flavor Pack (2 g)

UPC Codes:

343386202027

Lot Numbers:

S800175 (Exp 31-Dec-20)

Date Ranges: 31-Dec-20

Product: Cherry Flavor Pack (2 g)

Lot Numbers:

S800401 (Exp 28-Feb-21)

S800426 (Exp 31-Mar-21)

S800920 (Exp 31-Aug-21)

Date Ranges: 28-Feb-21, 31-Mar-21, 31-Aug-21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82396

Status: Resolved

Manufacturer: LUPIN SOMERSET

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 76422 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if you have Gavilyte-N Oral Solution by checking the bottle for NDC 43386-050-19 and UPC 343386050192.

Check the flavor packets and lot numbers on your packaging to see if they match the following: Lemon Flavor Pack (UPC 343386200023, Lot S800021, Exp 30-Nov-20); Orange Flavor Pack (UPC 343386202027, Lot S800175, Exp 31-Dec-20); or Cherry Flavor Pack (UPC 3433862034, Lots S800401, S800426, or S800920 with Expiration dates through 31-Aug-21).

Contact your healthcare provider or pharmacist for guidance if you have an affected kit, especially if you have sensitivities to specific flavorings.

Return any unused product to the pharmacy for a refund and contact the manufacturer, Lupin Somerset, at their New Jersey location (400 Campus Dr, Somerset, NJ) for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution

Model:

NDC 43386-050-19

UPC Codes:

343386050192

Lot Numbers:

S800021 (Exp 30-Nov-20)

S800175 (Exp 31-Dec-20)

S800401 (Exp 28-Feb-21)

S800426 (Exp 31-Mar-21)

S800920 (Exp 31-Aug-21)

Date Ranges: Expiration dates: 30-Nov-20, 31-Dec-20, 28-Feb-21, 31-Mar-21, 31-Aug-21

Product: Lemon Flavor Pack (2 g)

UPC Codes:

343386200023

Lot Numbers:

S800021 (Exp 30-Nov-20)

Date Ranges: 30-Nov-20

Product: Orange Flavor Pack (2 g)

UPC Codes:

343386202027

Lot Numbers:

S800175 (Exp 31-Dec-20)

Date Ranges: 31-Dec-20

Product: Cherry Flavor Pack (2 g)

Lot Numbers:

S800401 (Exp 28-Feb-21)

S800426 (Exp 31-Mar-21)

S800920 (Exp 31-Aug-21)

Date Ranges: 28-Feb-21, 31-Mar-21, 31-Aug-21