Novis PR, LLC dba Kramer Novis recalls G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal…

Recall date

April 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0868-2023

FDA classification

Class I

Brand / firm

Novis PR, LLC dba Kramer Novis

Sold / distributed

Puerto Rico

Why it was recalled

Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01