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Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV us...

FDA Recall #D-0570-2025 — Class I — June 27, 2025

Recall #D-0570-2025 Date: June 27, 2025 Classification: Class I Status: Ongoing

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

Recalling Firm

Sandoz Inc — Princeton, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

unknown

Distribution

Nationwide in the USA

Code Information

Lot # PG4360, PG4362, Exp. 11/30/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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