The US Food and Drug Administration (FDA) announces that Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial (lot number: PG4362). The lot is being recalled due to a customer complaint indicating that 4 vials incorrectly labelled as Penicillin G Potassium for Injection, USP, 20 million Units were included in cartons (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection, USP, 1 gram per vial. This is an update to the Company Statement issued on June 27, 2025, to include one additional lot.
There is a reasonable probability that the inadvertent administration of cefazolin injection following dosing recommendation of penicillin G potassium injection due to mislabeling may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, and delayed recovery.
To date, Sandoz has not received any reports of adverse events or injuries related to the product mislabeling. Sandoz has received a complaint of administration of the incorrectly labelled product to a patient.
Cefazolin for Injection USP is used for the treatment of infections caused by certain bacteria in many different parts of the body including the treatment of pneumonia. Cefazolin for Injection USP can also be used to prevent infections, before and after surgery. Antibacterial drugs like Cefazolin for Injection USP treat only bacterial infections. They do not treat viral infections. Cefazolin for Injection USP is indicated for adult, elderly, pediatric patients, including newborn term infants.
Penicillin G Potassium for Injection is indicated in the treatment of certain serious infections including septicemia, skin and wound infections. It is also approved for the treatment of diphtheria, community-acquired pneumonia, peritonitis, meningitis/brain abscesses, osteomyelitis, infections of the genital tract, anthrax, tetanus, gas gangrene, listeriosis, pasteurellosis, rat bite fever, fusospirochetes, actinomycosis, complications in gonorrhea and syphilis and Lyme. To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs, Penicillin G Potassium for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Penicillin G Potassium for Injection is indicated for use in adults, adolescents, children, pediatric, newborn infants and preterm infants.
Although both Cefazolin and Penicillin G Potassium belong to the beta-lactam group of antibiotics, they are indicated for different types of infections, and the spectrum of susceptible organisms also differs. Additionally, while the patient populations overlap, each medicine has specific on-label distinct groups, and the dosing regimens may differ, as well.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-sandoz-inc-issues-voluntary-nationwide-recall-expansion-one-additional-lot-cefazolin
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 28 Jun 2025.
Ends/Tuesday, Jul 15, 2025
Issued at HKT 14:45
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