Decongestant Recall?

For a variety of historical reasons, some presciption medications, mostly older products, continue to be marketed in the US having never obtained FDA approval. These products have been previously grandfathered and did not require approval since they pre-date the FDA process.

June 2006 , the FDA announced that the agency will begin to crack down on these unapproved products and require their removal from the market unless manufacturers submit applications for approval.

Also in June, the FDA took action on its first target of unapproved products, by ceasing the manufacturing of unapproved products containing carbinoxamine (antihistamine). Many currently marketed cough/cold products contain carbinoxamine. As pharmacies use up current inventories these products may be unavailable to patients.

For further informatin, please see the FDS's Unapproved Drugs web page, located at www.fda.gov/cder/drug/unapproved_drugs/default.htm.