Drug Enforcement D-0868-2023

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

Status

Terminated

Classification

Class I

Report Date

June 7, 2023

Termination Date

September 13, 2024

Product Information

Product description
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
Product quantity
9077 bottles
Reason for recall
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Puerto Rico

Location & Firm

Recalling firm
Novis PR, LLC dba Kramer Novis
Address
320 Ave Barbosa, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0868-2023
Event ID
92324
Recall initiation date
April 20, 2023
Center classification date
June 6, 2023
Code info
Lot: D20911, Exp. Oct/25
More code info
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