Home / Recalls / Novel Laboratories, Inc. d.b.a LUPIN / D-0726-2021

D-0726-2021 Class II Terminated

Recalled by Novel Laboratories, Inc. d.b.a LUPIN — Somerset, NJ

Recall Details

Product Type: Drugs
Report Date: August 25, 2021
Initiation Date: July 29, 2021
Termination Date: November 14, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20,814 bottles

Product Description

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 Pattern

Nationwide

Code Information

Lot S001133, exp 7/2022