注射用头孢唑林，1克小瓶因青霉素G钾而召回, USA

United States

Update July 14th, 2025:
Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection, USP, 1 gram per vial.

Lots impacted by the voluntary recall and its expansion:

- Product Name: Cefazolin for Injection, USP (25 by 1g vials)
- Vial NDC: 0781-3451-70
- Carton NDC: 0781-3451-96
- Lot Number: PG4362
- Expiration Date: 2027-NOV
- Manufacturer: Sandoz GmbH
- Distributor: Sandoz Inc

- Product Name: Penicillin G Potassium for Injection, USP
- Vial NDC: 0781-6136-94
- Carton NDC: N/A
- Lot Number: PG4362
- Expiration Date: 2027-NOV
- Manufacturer: Sandoz GmbH
- Distributor: Sandoz Inc

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-sandoz-inc-issues-voluntary-nationwide-recall-expansion-one-additional-lot-cefazolin


June 27th, 2025:
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. This single lot is being recalled due to a customer complaint indicating that four (4) Penicillin G Potassium for Injection, USP, 20 million Units labelled vials were incorrectly included in a carton (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. Sandoz has received a complaint of inadvertent administration of the incorrect product to a patient.

Risk Statement: There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, 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, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment, and delayed recovery. The product being recalled was shipped to select wholesalers for further distribution nationwide.

- Product Name: Cefazolin for Injection, USP (25 by 1g vials)
- Vial NDC: 0781-3451-70
- Carton NDC: 0781-3451-96
- Lot Number: PG4360
- Expiration Date: 2027-NOV
- Manufacturer: Sandoz GmbH
- Distributor: Sandoz Inc

- Product Name: Penicillin G Potassium for Injection, USP
- Vial NDC: 0781-6136-94
- Carton NDC: N/A
- Lot Number: PG4360
- Expiration Date: 2027-NOV
- Manufacturer: Sandoz GmbH
- Distributor: Sandoz Inc

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.



Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging