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.

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