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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Audience: Consumer, Health Professional, Pharmacy

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.

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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm¹
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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