Cefazolin Sodium

Swiss generics and biosimilars maker Sandoz issued a voluntary recall of one lot of the antibacterial drug Cefazolin due to a crucial packaging error. Sandoz, the Swiss generics and biosimilars specialist that spun off from Novartis two years ago, has issued a voluntary recall of one lot of the antibacterial drug cefazolin thanks to a crucial packaging error.The drugmaker telegraphed the product pull in a letter posted on the FDA’s safety and recall webpage on June 27.The company initiated the lot pull after a customer complained of finding four injectable penicillin G potassium vials in a cefazolin carton. As of Friday, Sandoz said it hadn't received any adverse event or injury reports tied to the mix-up, though it did receive a complaint that the incorrect product was administered to a patient.The recall covers a single batch of injectable cefazolin that was slated to expire in November 2027. Sandoz did not specify where the product was packaged in its recall notice. Cefazolin is an antibacterial used to treat infections caused by certain bacteria, including pneumonia. Penicillin G potassium, on the other hand, is reserved for the treatment of certain serious infections including septicemia and skin and wound infections. The product is used sparingly to help reduce the development of drug-resistant bacteria and maintain the medication's effectiveness, Sandoz explained. While cefazolin and penicillin G potassium both belong to the beta-lactam group of antibiotics, they are indicated for different types of infections, and the range of susceptible organisms also differs. Additionally, the company said, each medicine has specific on-label distinct groups, and the dosing regimens may also differ."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," Sandoz warned in its letter. Aside from the wrong medication offering "less than optimal treatment of severe infections," patients who receive penicillin by mistake could also suffer serious allergic reactions, drug interactions, heart arrhythmias and "delayed recovery," Sandoz noted. Sandoz, one of the world's top producers of generic and biosimilar medicines, formally split off from Switzerland's Novartis in October 2023. Since then, the company has continued to strike deals and expand its manufacturing footprint, including building out a production presence in Slovenia.  More recently, however, the company's CEO, Richard Saynor, has been critical of the effect the Trump administration's potential pharmaceutical tariffs could have on U.S. generics and on patient access to medicines more broadly. Speaking to Reuters in late April, Saynor said that Sandoz may have to pull some of its products from the U.S. market if pharmaceutical import tariffs are imposed. 

Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Penicillin G Potassium Injection Vial Company Name: Sandoz Inc. Brand Name: Product Description: Product Description Cefazolin for Injection, USP, 1 gm vial Company Announcement 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. 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. To date, Sandoz has not received any reports of adverse events or injuries related to this recall. Sandoz has received a complaint of inadvertent administration of the incorrect product to a patient. Product Name Vial NDC Carton NDC Lot Number Expiration Date Manufacturer Distributor Cefazolin for Injection, USP (25 by 1g vials) 0781-3451-70 0781-3451-96 PG4360 2027-NOV Sandoz GmbH Sandoz Inc Penicillin G Potassium for Injection, USP 0781-6136-94 N/A PG4360 2027-NOV Sandoz GmbH 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. Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distribution nationwide. Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 491-7872 or by email at Sandoz6004@sedgwick.com . For questions about the recall process, please call Sedgwick at (844) 491-7872 between the hours of 8:00 AM to 5:00 PM Monday - Friday (EST). Please report any adverse reactions by calling Sandoz at (800) 525-8747. Customer service agents are available from 8:30 AM to 5:00 PM (EST), Monday-Friday, except on national holidays. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Company Contact Information Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.