FDAHealthJune 27, 2025
Sandoz Inc — 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
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 27, 2025
Nationwide in the USA
What's affected?
- 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.
- Lot code
- PG4360
Additional details
Lot # PG4360, PG4362, Exp. 11/30/2027
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: unknown.
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