D-0570-2025 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2025
- Initiation Date
- June 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Reason for Recall
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Distribution Pattern
Nationwide in the USA
Code Information
Lot # PG4360, PG4362, Exp. 11/30/2027