Neligen Pharma Inc. and Advent Pharmaceutical have recalled all prescription cough and cold drug products sold on or after March 5, 2008. According to the press release by the U.S. Food and Drug Administration (FDA), Neligen Pharma and Advent Pharmaceutical are contract manufacturers for these products and are recalling the drugs because of the unapproved drug product category.
Patients who are taking these recalled drugs are urged to stop taking them and to return the products to the place where purchased. In addition, patients are supposed to contact their physicians to obtain a replacement medication or prescription.
According to the FDA, consumer’s exposure to the recalled drugs is not likely to cause any adverse health complications, although the safety and effectiveness have not been established by the FDA yet. The two drug manufacturers have stopped producing the products. There have been no reported injuries to date.
The FDA press release states that any questions relating to the drug recall by Neligen Pharma and Advent Pharmaceutical should be directed to Advent Pharma Customer Service at 888-634-5522. Customer Service is available Monday through Friday from 8:00 AM to 5:00 PM EST.
Any adverse reactions to the drugs should be reported to the FDA’s Adverse Reporting program either online, by fax or mail.