Naperville pharmacy recalling compounded medications
A Naperville pharmacy is issuing a voluntary recall of medications that were prepared on site after inspectors raised concerns about whether the shop kept its drugs sterile.
Martin Avenue Pharmacy, which prepares custom and flavored medications for people and pets, is recalling all "in-date compounded sterile preparations," according to a news release from the business.
"The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality-control procedures that present a risk to sterility assurance," the pharmacy's statement said.
The facility was inspected between June 30 and July 21, according to FDA documents. Inspectors listed 15 observations about drug preparation procedures, some of which could result in compounded medications not remaining sterile.
Medications classified as "compounded sterile preparations" have been mixed or altered by a pharmacist to create a combination that meets the needs of an individual patient, according to an FDA question and answer list about the practice of compounding. Compounded medications can be helpful for patients who have an allergy to one specific dye or ingredient or for patients who are unable to swallow pills.
If a patient takes a compounded medication that is not sterile, he or she would be at risk for infection, Martin Avenue Pharmacy said in its statement. The pharmacy has not heard of any patients with infections, illnesses, injuries or other complaints after taking compounded medications it provided.
The recall affects all compounded sterile preparations issued until Aug. 20 to patients or pharmacies in Illinois and six other states including Alabama, Florida, Michigan, Ohio, Texas and Wisconsin. Patients who have received these drugs are asked to stop taking them and mail them to the pharmacy at 1247 Rickert Drive, Suite 100, in Naperville.
A list of recalled medications is available at martinavenue.com/voluntaryrecall/. Adverse reactions or quality problems can be reported to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/.