FDA-Drug2023-06-07Class I

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

Novis PR, LLC dba Kramer Novis
Hazard

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

Sold states
Puerto Rico
Affected count
9077 bottles
Manufactured in
320 Ave Barbosa, N/A, San Juan, PR, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0868-2023

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