Recall Enforment Report D-0545-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 07-10-2025 for the product Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04 The product was recalled due to cgmp deviations; particulates identified during visual inspection. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0545-202507-10-202508-06-2025Class II19,279 vialsBicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04CGMP Deviations; particulates identified during visual inspectionOngoing
D-0544-202507-10-202508-06-2025Class II50,855 2 mL vialsBicillin 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 - 60793-701-02CGMP Deviations; particulates identified during visual inspectionOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
60793-700Bicillin L-a Penicillin G BenzathineInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-701Bicillin L-a Penicillin G BenzathineInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-702Bicillin L-a Penicillin G BenzathineInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer IncHuman Prescription Drug