Pfizer recalls dopamine injection lot; two Phase 3 trials remain not yet recruiting

Pfizer's week includes a new drug recall alongside two Phase 3 trials still listed as not yet recruiting.

• Pfizer initiated a Class II recall (D-0853-2026) of Dopamine HCl Injection, USP, 200 mg/5 mL, citing a lack of assurance of sterility for lot NL5230, expiring 10/2027, distributed nationwide in the US.¹ The recall was firm initiated on a voluntary basis¹, with status listed as ongoing¹.
• Tilrekimig (PF-07275315), a subcutaneous injection for moderate-to-severe COPD, remains registered under an open-label extension trial (NCT07839884, study C4531015) for patients completing parent study C4531031, designed so the study will primarily characterize the safety and tolerability of longer-term exposure to tilrekimig². The trial lists an estimated enrollment of 1360 participants² and a primary completion date of 2034-05-12 (estimated).
• RSVpreF, Pfizer's RSV vaccine, remains registered in a Phase 3 pediatric trial (NCT07839871, study C3671017) for children ages 5 to under 18 at high risk of RSV disease, where the study will first enroll immunocompetent, RSV-experienced participants before enrolling immunocompromised participants to allow for safety data review³. The trial plans to enroll 920 participants (estimated)³ with a primary completion date of 2031-04-01 (estimated).