April 2023 FDA Recall G-supress Dx by Novis Pr, Llc Dba Kramer Novis
D-0868-2023 - Product mix-up
This Class I drug recall was voluntarily initiated by Novis Pr, Llc Dba Kramer Novis on April 20, 2023 for the product G-supress Dx. The FDA reported the reason for recall as product mix-up. The product was distributed in Puerto Rico and the recall is currently terminated.
Recall Number: D-0868-2023
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
04-20-2023
06-07-2023
9077 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novis PR, LLC dba Kramer Novis
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Puerto Rico
09-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: D20911, Exp. Oct/25
