Drug Safety Alerts

PECGEN DMX Consumer-Level Recall

05/31/2019

On May 31, 2019, the United States Food and Drug Administration (FDA) issued a MedWatch regarding a consumer-level recall of PECGEN DMX liquid cough syrup NDC 52083-630-16.This recall was issued because product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age. Error was discovered by an email notification of an unidentified individual alerting of incorrect information in label.

The recall affects lot numbers D80202 exp. 02/20, D80210 exp. 02/20, D80818 exp. 09/20, D80819 exp. 09/20 and D80820 exp. 09/20.

There is no evidence that cough and cold medicines are safe or effective for young children. However, there is evidence that children have been harmed by overdoses of these products. Problems include seizures, coma, and death. Dextromethorphan can also interact with Tylenol or other cough/cold medications to be highly toxic—more than if given alone. To date, NOVIS PR LLC has not received any reports of adverse events related to this recall.

PECGEN DMX was distributed in Puerto Rico to Wholesalers and retail pharmacies. Product is only sold in Puerto Rico.

Novis PR LLC is notifying its distributors and customers by letters and phone calls the collection of the units and is arranging the return of all recalled products.

Consumers who have PECGEN DMX which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.

Distributors/retailers that have PECGEN DMX which is being recalled should stop distributing the product and must return it to place of purchase.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Novis PR LLC at 1-787-767-2072, (AST). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.