Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| BCG | BCG (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
BCG - Drug ineffective (took BCG from 2011 to 2014); This spontaneous report was received from a consumer and refers to currently 68-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in 2011, the patient started therapy with BCG (TICE BCG LIVE) (dose, frequency, route of administration, lot #, expiration date, and indication were not reported). On an unknown date, the patient experienced BCG - Drug ineffective (he took BCG (TICE BCG LIVE) from 2011 to 2014). The outcome of Drug ineffective was unknown. The action taken with BCG (TICE BCG LIVE) regarding the event was unknown. The causal relationship between the event of drug ineffective and BCG (TICE BCG LIVE) was considered related. Lot # is being requested and will be submitted if received.