Reported May 25, 2022 · Terminated

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

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Is this the product you have?

    • GaviLyte -C (Polyethylene Glycol 3350
    • 240 g) and electrolytes for Oral Solution
    • USP with flavor pack NDC# 43386-060-19
Lot codes and dates
    • Lot # S001132
    • exp. date July 2022 NDC # 43386-060-19
Amount recalled
26,910 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Stability Specification

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 13, 2023 · Data as of Sep 19, 5:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.