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 S001133exp 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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