Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| BCG | BCG (TICE) | ORGANON-TEKNIKA | UNK | Y011796 | — |
poor quality product administered; HCP states that they did not receive any DILUENT with the orders and do not have lot and expiration dates for the DILUENT they used to reconstitute; This spontaneous report was received from a health care professional (HCP) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with bacille Calmette-Guerin (TICE BCG LIVE) for an unknown indication. On 13-Feb-2025, the patient had poor quality product administered (Poor quality product administered); 2 lots were reported: lot #Y011796, expiration date: 03-Jul-2025 and lot #y017668 expiration date: 23-OCT-2025. Upon receipt of the bacille Calmette-Guerin (TICE BCG LIVE) they found that the powder in all the vials was "as hard as a rock and stuck to the bottom of the vials", color was cream white. They reconstituted and administered 3 of them. HCP states that they did not receive any diluent with the orders and do not have lot and expiration dates for the diluent they used to reconstitute (Product preparation error). No further information provided.