Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4930 | — |
There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance; This is a spontaneous report received from an Other HCP from product quality group. No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: LN4930, Expiration Date: 31Jul2026) for immunisation. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance". Additional information: the reporter stated that they have Prevnar 20, a couple boxes of it. Confirmed that the product was not administered to patient. Noticed that there was a growth of some sort in the vial in the prefilled syringe. It was like a tan color substance. Causality for "there was a growth of some sort in the vial, in the prefilled syringe; a tan color substance" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).