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Class II · ModerateRecall completed

Gavilyte - C

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # S001132, exp. date July 2022 NDC # [redacted-phone]
Where it was soldProduct was distributed nationwide, including Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Stability Specification

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Pharmaceuticals,Inc.
Brand nameGAVILYTE - C
Generic namePOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK
Active ingredient(s)POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS
Distributed by / forLupin Pharmaceuticals Inc.
NDC43386-060-19
Show the full FDA record
Full product labelGaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed nationwide, including Puerto Rico.
Quantity26,910 bottles
Recall initiated2022-04-27
Report date2022-05-25
Recall completed2023-04-13
Recall numberD-0875-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.