Reported Aug 25, 2021 · Terminated

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel…

Novel Laboratories, Inc. d.b.a LUPIN

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: Novel Laboratories, Inc. d.b.a LUPIN · 400 Campus Dr · Somerset, NJ · 08873-1145

Is this the product you have?

  • GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
Lot codes and dates
    • Lot S001133
    • exp 7/2022
Amount recalled
20,814 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specification; Out of specification for Osmolarity

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 Nov 14, 2022 · Data as of Sep 19, 5:05 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.