FDA-Drug2021-08-25Class II
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
Novel Laboratories, Inc. d.b.a LUPIN
Hazard
Failed Stability Specification; Out of specification for Osmolarity
Sold states
Nationwide
Affected count
20,814 bottles
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0726-2021Don't want to check this manually?
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