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U.S. Department of Health and Human Services

Consumers: Case Study 1 – Drug Quality Problem

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Karen D. is a 35 year old married Caucasian woman, employed as a occupational therapist at Anytown Medical Center in Anytown, Maryland who was seen by her regular skin doctor, Dr. Fleming, for a six week history of worsening redness and swelling of her feet. Karen had noted intense redness, itching and scaling of the skin around all toes on each foot, right more than left. She more recently had cracking of the skin between several toes and a small amount of clear drainage. Dr. Fleming’s examination suggested the diagnosis of a fungal dermatitis and a new antifungal solution was prescribed for application to the affected areas. On April 3, Karen purchased her medication, named FungusStop, at a nearby EZStop Pharmacy. The product is manufactured by XYZ Pharmaceuticals and is supplied in a 25 mL glass vial, 250 mg/cc with an applicator tip provided to be inserted in the sealed, stoppered neck of the vial.

On examining the vial after returning home and reading the package insert instructions, Karen noticed unusual particles within the glass vial. She opened the vial by taking off the stopper and removed three irregular pieces of what appeared to be glass, the largest of which measured approximately ¼ inch by ¼ inch. She returned to the pharmacy immediately and showed the medication to the pharmacist, who agreed that, while the vial appeared to be intact, there were particles within the solution.

The pharmacist examined the remaining vials that were received from the distributor from the same lot, and by visual inspection did not observe any other vials with partiicles in the solution. Nevertheless, she told Karen that she planned to set aside the entire remaining supply of the drug product in case further direct inspection was required.

Karen knew from her hospital work about reporting product quality problems to FDA and asked the pharmacist for the internet address for FDA’s MedWatch program, www.fda.gov/medwatch/report.htm. She also requested that the pharmacist provide the NDC number (12345-678-90) that identifies this specific brand, the type of medication, and the lot number, # A12345BC, for this specific ‘batch’ of vials.

Section A – About the Problem

What kind of problem was it? (Check all that apply)

Did any of the following happen? (Check all that apply)



For a problem with a product, including

  • prescription or over-the-counter medicine
  • biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments and bone) and gene therapies
  • nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods
  • tobacco and nicotine products, including those to help you quit
  • cosmetics or make-up products
Go to Section B

For problems with a medical device, including

  • any health-related test, tool, or piece of equipment
  • health-related kits, such as glucose monitoring kits or blood pressure cuffs
  • implants, such as breast implants, pacemakers, or catheters
  • other consumer health products, such as contact lenses, hearing aids, and breast pumps
Go to Section C
(Skip Section B)
Section B – About the Product
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
Do you still have the product in case we need to evaluate it? (Do not send the product to FDA.
We will contact you directly if we need it.)
Go to Section D (skip section C)
Section C – About the Medical Device
Was someone operating the medical device when the problem occurred?
If yes, who was using it?

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.):

Go to Section D
Section D – About the Person Who Had the Problem
Sex
Go to Section E
Section E – About the Person Filling Out This Form

We will contact you only if we need additional information. Your name will not be given out to the public.

Did you report this problem to the company that makes the product (the manufacturer)?
May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?
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