FDA recall D-0544-2025

Pfizer Inc. · Class II · drug

Product

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

Reason for recall

CGMP Deviations; particulates identified during visual inspection

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-07-10
Report date: 2025-08-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0544-2025