FDA recall D-1113-2019

Product

Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034

Reason for recall

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-03-19

Report date

2019-04-17

Termination date

2022-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1113-2019