Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
No additional AE; Pharmacist calling to report missed dose of TICE BCG.; Pharmacist calling to report missed dose of TICE BCG.; This spontaneous report was received from a pharmacist referring to a 68-year-old patient. The patient's pertinent medical history, known drug allergies or reactions, and concomitant therapies were not reported. On an unspecified date, the patient started therapy with TICE Bacillus Calmette-Guerin (BCG) (strength, formulation, dose, frequency, route of administration, indication, lot #, and expiration date were not reported). Pharmacist reported that on 17-OCT-2025, the patient missed a dose of TICE BCG. Pharmacist noted that a nurse had successfully prepared the TICE BCG but due to mishandling, the patient was not able to receive their dose (Product administration error, Product dose omission issue). The TICE BCG was unable to be successfully administered due to an error surrounding the administration of TICE BCG with the catheter. The term "mishandling" was used to encompass the unspecified issue that occurred either before, during or after the catheter insertion. The source of that error was unknown as it might or might not be due to patient factors or the competency of the nurse administering the TICE BCG. Pharmacist reassured the patient had been rescheduled to receive their dose on the next day. No additional adverse event. Lot number is being requested and will be submitted if received.