Medications & Supplements/Prescription Drugs

GaviLyte-C Oral Solution Recalled for Failed Stability Specification

Agency Publication Date: May 17, 2022

Summary

Lupin Pharmaceuticals Inc. is recalling 26,910 bottles of GaviLyte-C (Polyethylene Glycol 3350 and electrolytes) for Oral Solution because the product failed stability testing. GaviLyte-C is a prescription medication used to clean the bowel before a colonoscopy. No injuries or incidents have been reported in connection with this recall.

Risk

A failed stability specification means the medication may not maintain its intended potency or chemical properties through its expiration date, which could make the treatment less effective. No specific injuries have been reported.

What You Should Do

This recall affects GaviLyte-C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack, identified by NDC number 43386-060-19.
Check your medication for lot number S001132 with an expiration date of July 2022.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack

Variants: flavor pack

Lot Numbers:

S001132 (Exp July 2022)

NDC:

43386-060-19

Quantity: 26,910 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90094

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 26,910 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

What You Should Do

This recall affects GaviLyte-C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack, identified by NDC number 43386-060-19.

Check your medication for lot number S001132 with an expiration date of July 2022.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.