A Florida pharmacy’s problems: abscesses, rashes, and a recall of pet and people drugs
“A lack of sterility assurance” spurred a Florida pharmacy to recall five drugs it created for people and two drugs it made for pets.
Here’s what you need to know about the action involving APS Pharmacy, a compounding pharmacy owned by Drug Depot and run out of the Palm Harbor area of Pinellas County.
What drugs are recalled?
The recalled drugs, which were sent to customers nationwide, include human drugs “Gonadorelin;” “Gonadorelin acetate;” “Testosterone cypionate in grapeseed oil;” “Testosterone cypionate/anastrozole in grapeseed oil;” “Testosterone cypionate/DHEA in grapeseed oil;” and “testosterone cypionate/propionate in sesame seed oil;” and animal drugs “Cyclosporin” and “Tacrolimus.”
APS, which compounded the drugs Dec. 21 through March 7, initiated the recall March 15. The FDA posted a PDF of the drugs.
The FDA said Tuesday that since that recall, the agency has received “adverse event” reports of “injection site reactions, such as pain, redness, swelling and abscesses requiring medical treatment; and systemic reactions, which include fever, chills, and rash.”
What are compounded drugs?
Compounded drugs mix different ingredients to create a drug tailored to the specific needs of the patient. Compounded drugs are not FDA-approved.
“A drug may be compounded for a patient who cannot be treated with an FDA-approved medication,” the FDA said, “such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.”
Sterility problems at compounding pharmacies aren’t uncommon, however.
What should you do now?
If you know you have one of the recalled drugs, contact your medical professional if you’re a patient. Find another compounding pharmacy without sterility issues if you’re a medical professional.
If you have a problem with these or any other drugs, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
This story was originally published April 28, 2022 at 9:18 AM with the headline "A Florida pharmacy’s problems: abscesses, rashes, and a recall of pet and people drugs."
