LUPIN recalls GaviLyte C PEG-3350 oral solution due to failed stability testing. The product may have incorrect osmolarity levels, which could affect safety for medical use. Consumers should contact LUPIN for details.
Failed Stability Specification; Out of specification for Osmolarity
LUPIN is recalling GaviLyte C PEG-3350 oral solution because it failed stability testing and may have incorrect osmolarity levels. This could affect the safety of the product for medical use, especially in critical health situations.
The product failed stability testing and has out-of-specification osmolarity levels. This means the solution may not have the correct concentration of salts and water, which could lead to improper medical effects if used.
People who have the GaviLyte C PEG-3350 (240g) oral solution with NDC 43386-060-19 and lot S001133 (expiring 7/2022) are affected. Those using this solution for medical purposes are most at risk.
Check for the product name 'GaviLyte C PEG-3350 (240g) with Flavor Pack'. Look for NDC code 43386-060-19 and lot number S001133 (expiring 7/2022).
Identify the NDC code 43386-060-19 and lot number S001133 on the product label.
The recall states the product failed stability testing and has out-of-specification osmolarity levels, which could affect safety. The official notice does not specify if it's safe to use.
The recall remedy is not stated in the official notice, so there is no specific action required. Contact LUPIN for further details.
Check for the product name 'GaviLyte C PEG-3350 (240g) with Flavor Pack', NDC code 43386-060-19, and lot number S001133 (expiring 7/2022).
We’ve drafted a message you can send LUPIN to request your refund or repair — edit it as you like.
Subject: Recall D-0726-2021 — LUPIN LUPIN Hello, I own a LUPIN that is covered by recall D-0726-2021 from LUPIN. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
