Drug Enforcement D-0569-2025

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

Status

Ongoing

Classification

Class I

Report Date

July 9, 2025

Termination Date

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Product Information

Product description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Product quantity
208,300 vials
Reason for recall
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Recall initiation reason
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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
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Codes & Dates

Recall number
D-0569-2025
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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