G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal
Summary
The FDA issued a Class I for G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Dr by Novis PR, LLC dba Kramer Novis. Reason: Product mix-up: incorrect product was found inside the G-Supress DX product carton..
Details
Source
Drug Recall
External ID
D-0868-2023
Action Date
2023-06-07
Status
Terminated
Category
drug
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
Lot/Code Info: Lot: D20911, Exp. Oct/25
Quantity Affected: 9077 bottles
Reason for Recall
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Distribution
Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-20
Company
San Juan, PR
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 243 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Novis PR, LLC dba Kramer Novis has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novis PR, LLC dba Kramer Novis) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novis PR, LLC dba Kramer Novis have FDA actions?
Novis PR, LLC dba Kramer Novis has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0868-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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