Drug recall: G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant…
Class I FDA enforcement event 92324. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class I, in the words of FDA
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
Novis PR, LLC dba Kramer Novis started this drug recall on 20 Apr 2023. The firm address in the FDA record is in San Juan, PR. FDA put the recall in Class I. FDA event 92324 has 1 product record. The first FDA enforcement report date is 7 Jun 2023. The record gives the status Terminated, with the termination date 13 Sep 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Puerto Rico
Recalling firm
Novis PR, LLC dba Kramer Novis, San Juan, PR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0868-2023 | 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… | 9077 bottles | Class I | Terminated | 7 Jun 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2023
- 281
- Share of these events in Class I
- 15%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Mar 2023 | GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 | Food | Class II | 3 |
| 25 Aug 2022 | G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novi | Food | Class III | 1 |
Official channels
- FDA enforcement report D-0868-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 92324. https://recallregister.com/fda/i/92324/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Puerto Rico
- What quantity of product is in FDA event 92324?
- The FDA record gives this quantity:
9077 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2023 have the same class?
- 15% of the 281 drug events that started in 2023 are in Class I.