Drug 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
D-0545-2025
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 97220
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19,279 vials
- Official record key
drug-enforcement:D-0545-2025
Official wording
Reason: CGMP Deviations; particulates identified during visual inspection
Code information: Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
particulates
-
Manufacturing or process control
CGMP Deviations