An emergency recall of children’s cough suppressants has been issued by Novis PR, LLC after it was found that some packages contain a lethal combination of ethyl alcohol and benzocaine. Consumption of the drug by children can result in near immediate coma and death. As of the writing of this notice, no adverse effects have yet been reported, but it is imperative that all consumers who utilize the drops check their packages immediately.
SUMMARY
Date of Recall:
Announced: May 18, 2023
Public Notification: May 19, 2023
Name(s) of Drug:
G-SUPRESS DX
Company Name:
Novis PR, LLC
Drug Indication:
Pediatric Cough Suppressant
Pediatric Expectorant
Pediatric Nasal Decongestant
Common Cold
Product Description
The drops are packaged in 0.5oz and 1 oz bottles that are sold in carton boxes. Packages also include the phrase, “Sugar & Alcohol FREE.” Product was distributed throughout Puerto Rico. The Spanish version of the FDA notice can be found here.
Reason for Recall
During manufacturing a product other than the intended drops was placed into the bottles. Ethyl Alcohol and Benzocaine, which can cause deadly side effects were packaged into the bottles without appropriate labeling. The cause of the mix-up has not yet been released.
Impacts
Infants and children who consume ethyl alcohol can develop hypoglycemic coma or hypothermia which may result in death if not treated immediately and aggressively in a medical setting. All consumers who utilize the product are at risk for developing methemoglobinemia, a rare blood disorder leading to:
- Cyanosis (blue skin)
- Pallor (pale skin)
- Fatigue (tiredness)
- Weakness
- Headache
- Lack of Coordination
- Poor Judgment
- Slow Breathing
- Confusion
- Slurred Speech
- Seizures
- Irregular Heart Rhythm
- Coma
- Death
Lot information
Consumers who have purchased G-SUPRESS DX should locate the box and bottle and find the lot number. If the lot number matches the number listed below, the medication is part of the recall. See below for further instructions.
| Product Description | Lot Number |
| G-SUPRESS DX | D20911 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
If you find that your lot of medication is part of this recall, do the following:
- DISCONTINUE USE OF THIS PRODUCT IMMEDIATELY.
- Notify your physician or pediatrician immediately if any of the recalled product has been consumed.
- Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
- Consumers may contact Novis PR LLC at 787-767-2072. They are available Mon-Fri from 8:00am to 4:00pm (EST). No email address has been provided.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact Novis PR LLC at 787-767-2072. They are available Mon-Fri from 8:00am to 4:00pm (EST). Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact Novis PR LLC at 787-767-2072. They are available Mon-Fri from 8:00am to 4:00pm (EST). Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
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