FDA recall D-0726-2021

Novel Laboratories, Inc. d.b.a LUPIN · Class II · drug

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

Reason for recall

Failed Stability Specification; Out of specification for Osmolarity

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2021-07-29
Report date: 2021-08-25
Termination date: 2022-11-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0726-2021