← FDA ENFORCEMENT
D-0570-2025Class I

Sandoz Inc

Recalling firm
Sandoz Inc
Product type
Drug
Status
Ongoing
Report date
2025-07-09
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
unknown
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.