Drug product
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.
D-0570-2025
Product summary
- Firm
- Sandoz Inc
- Event
- Event 97140
- Status
- Ongoing
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-0570-2025
Official wording
Reason: 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
Code information: Lot # PG4360, PG4362, Exp. 11/30/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up