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U.S. Department of Health and Human Services

Case Study 1 – Drug Product Problem

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Karen D. is a pharmacist working for a home health services pharmacy and is responsible for reconstituting the IV solutions that will be delivered to patients in several extended care facilities. On April 3, she took one vial of 200 mg of XYZ Pharmaceutical’s anti-fungal medication, NDC number 12345-678-90, and added 19 mL of sterile water for injection to the lyophilized powder to reconstitute the product.

On examining the vial after reconstitution, Karen noticed unusual particles within the vial. She opened the vial and removed three large pieces of what appeared to be glass, the largest of which measured approximately ¼ inch by ¼ inch.

Karen set aside the vial and examined the remaining vials that were received from the distributor from the same lot, Lot # A12345BC. On inspection, she observed three additional vials with small fragments that appeared to be glass. She set aside the entire supply of the drug product and notified her supervisor.

A. Patient Information


3. Sex

4. Weight

or

B. Adverse Effects, Product Problem or Error

1. Check all that apply: (?HelpUseful TipThe HIPAA Privacy Rule specifically permits pharmacists, physicians, nurses, or hospitals (i.e. covered entities) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.)


C. Product Availability

Product Available for Evaluation? (Do not send product to FDA)

D. Suspect Product(s)

E. Suspect Device


5. Operator of Device


8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?

F. Other (Concomitant) Medical Products

G. Reporter



2. Health Professional?
4. Also Reported to:
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