Drug Recall Enforcement Report Class I voluntary initiated by Novis PR, LLC dba Kramer Novis, originally initiated on 04-20-2023 for 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 The product was recalled due to product mix-up: incorrect product was found inside the g-supress dx product carton.. The product was distributed in Puerto Rico and the recall is currently ongoing.
Field Name |
Field Value |
Event ID |
92324 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number |
D-0868-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification |
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. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern |
Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
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 |
Reason For Recall |
Product mix-up: incorrect product was found inside the G-Supress DX product carton. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity |
9077 bottles Product Quantity The amount of product subject to recall. |
Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date |
06-07-2023 |
Recall Initiation Date |
04-20-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type |
Drugs |
Recalling Firm |
Novis PR, LLC dba Kramer Novis |
Code Info |
Lot: D20911, Exp. Oct/25 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages |
52083-655-01 |
Status |
Ongoing |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
52083-655 | G-supress Dx | Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride | Syrup | Oral | Kramer Novis | Human Otc Drug |