Cefazolin Injection Recalled for Incorrect Labeling as Penicillin G
Sandoz is recalling Cefazolin for Injection vials that were mislabeled as Penicillin G Potassium due to a labeling error. This mix-up poses serious medication error risks.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall, establishing a minimum severity score of 4. The labeling mix-up between two different medications creates serious potential for medication errors resulting in injury or death. No illnesses or deaths have been reported.
Plain-English summary
Sandoz Inc. is recalling certain vials of Cefazolin for Injection, USP 1 gram due to incorrect labeling identifying them as Penicillin G Potassium for Injection, USP 20 million units. The affected lots are PG4360 and PG4362, with an expiration date of 11/30/2027. These injectable antibiotics are distributed nationwide.
The labeling mix-up presents a serious risk of medication errors. Healthcare providers or patients who rely on the label may administer or receive the incorrect medication. Cefazolin and Penicillin G are different antibiotics used for different infections and have different potential adverse effects. Using the wrong antibiotic could result in treatment failure, allergic reactions (particularly in penicillin-allergic patients), serious infection, or other adverse health outcomes.
The recalled product
- Product
- PENICILLIN G POTASSIUM (PENICILLIN G POTASSIUM)
- Brand
- PENICILLIN G POTASSIUM
- Manufacturer
- Sandoz Inc
- Category
- Drug — Injectable Antibiotic
- Hazard
- mis-labeling
- medication-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # PG4360
- PG4362
- Exp. 11/30/2027
Distribution
Distributed nationwide across the United States.
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