Skip to content
Recall Observatory FDA recall evidence

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

D-0544-2025

July 10, 2025

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 97220
Status
Ongoing
Classification
Class II
Quantity
50,855 2 mL vials
Official record key
drug-enforcement:D-0544-2025

Official wording

Reason: CGMP Deviations; particulates identified during visual inspection

Code information: Lots: HJ3235, Exp 09/30/26; GL2954, HP6222, Exp, 01/31/27; HR9967, Exp 05/31/27; HP6232, LT5190,Exp 09/30/27; HP6228, Exp 10/31/27;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulates
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations