FDA-Drug2022-05-25Class II

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

Lupin Pharmaceuticals Inc.
Hazard

Failed Stability Specification

Sold states
Product was distributed nationwide, including Puerto Rico.
Affected count
26,910 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0875-2022

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