D-0570-2025 Class I Ongoing

Recalled by Sandoz Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
July 9, 2025
Initiation Date
June 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

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

Distribution Pattern

Nationwide in the USA

Code Information

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