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
Recall Number: D-0726-2021
Firm: Novel Laboratories, Inc. d.b.a LUPIN
Classification: Class II
Status: Terminated
Report Date: 20210825
Initiation Date: 20210729
Termination Date: 20221114
Reason for Recall
Failed Stability Specification; Out of specification for Osmolarity
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