Skip to content
Recall Observatory FDA recall evidence

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

June 27, 2025

Class I

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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up