FDA recall D-0868-2023

Product

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

Reason for recall

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

Distribution

Puerto Rico

Key facts

Status

Terminated

Initiation date

2023-04-20

Report date

2023-06-07

Termination date

2024-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Juan, PR, United States

Primary source

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