Status
Ongoing
Drug Enforcement D-0545-2025
CGMP Deviations; particulates identified during visual inspection
Classification
Class II
Report Date
August 6, 2025
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 19,279 vials
- Reason for recall
- CGMP Deviations; particulates identified during visual inspection
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0545-2025
- Event ID
- 97220
- Recall initiation date
- July 10, 2025
- Center classification date
- July 30, 2025
- Code info
- Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
- More code info
- —