Drug product
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
D-0569-2025
Product summary
- Firm
- Sandoz Inc
- Event
- Event 97140
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 208,300 vials
- Official record key
drug-enforcement:D-0569-2025
Official wording
Reason: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
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