The label contains incorrect dosage information
June 5, 2019Novis PR is recalling five lots of liquid cough syrup PECGEN DMX.
The product label contains incorrect dosage information and fails to advise consumers to consult a doctor for children under 2 years of age.
The recalled product, packaged in Amber plastic 16-oz., bottles in cases of 12 units with NDC 52083-630-16, include the following lot numbers and expiration dates:
- D80202, Exp date 02/20
- D80210, Exp 02/20
- D80818, Exp 09/20
- D80819, Exp 09/20
- D80820, Exp 09/20.
It was distributed in Puerto Rico to wholesalers and retail pharmacies and is sold only in Puerto Rico.
What to do
Novis PR LLC is notifying customers by letters and phone calls and arranging the return of all recalled products.
Customers who purchased the recalled product should stop using it and return it to place of purchase or discard it.
Consumers with questions may contact Novis PR at (787) 767-2072 Monday thru Friday, 7:30am 4:30pm (AST), or by email at info@kramernovis.com.