G-supress Dx Syrup
FDA Recall NDC 52083-655
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with G-supress Dx (NDC 52083-655). A significant event, classified as Class I, was initiated on Apr 20, 2023 by Kramer Novis. The reported reason for this action was: "Product mix-up: incorrect product was found inside the G-Supress DX product carton."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Apr 20, 2023
Jun 07, 2023
9077 bottles
Recall Profile & Regulatory Data
Event ID
92324
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Novis PR, LLC dba Kramer Novis
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Puerto Rico
Termination Date
Sep 13, 2024
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
Batch or Lot Expiration Information
Lot# Lot: D20911, Exp. Oct/25
Affected Packages Involved in this Recall
52083-655-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
