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 Laboratori
Recalled August 25, 2021 · FDA recall D-0726-2021 · Novel Laboratories, Inc. d.b.a LUPIN
Hazard
Failed Stability Specification; Out of specification for Osmolarity · FDA Class II
Units
20,814 bottles
Sold at
Nationwide
Description
Failed Stability Specification; Out of specification for Osmolarity
Product
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
Manufacturer(s)
Novel Laboratories, Inc. d.b.a LUPIN
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →