Novel Laboratories, Inc. d.b.a LUPIN recalls GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laborator…

Recall date

July 29, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0726-2021

FDA classification

Class II

Brand / firm

Novel Laboratories, Inc. d.b.a LUPIN

Sold / distributed

Nationwide

Why it was recalled

Failed Stability Specification; Out of specification for Osmolarity

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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