Drug Enforcement D-0570-2025

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

Status

Ongoing

Classification

Class I

Report Date

July 9, 2025

Termination Date

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Product Information

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.
Product quantity
unknown
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
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Sandoz Inc
Address
100 College Rd W

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0570-2025
Event ID
97140
Recall initiation date
June 27, 2025
Center classification date
August 6, 2025
Code info
Lot # PG4360, PG4362, Exp. 11/30/2027
More code info
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