Sandoz Cefazolin Recall

Sandoz is recalling one lot of mispackaged Cefazolin for Injection USP, 1 gram per vial due to a customer complaint indicating that a 25 vial carton included four vials of Penicillin G Potassium for Injection USP, 20 million Units.

Cefazolin for Injection, USP (25 by 1g vials)

• Vial National Drug Code (NDC) 0781-3451-70
• Carton NDC 0781-3451-96
• Lot Number PG4360
• Expiration Date 2027-NOV.
  
  

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. 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.

Background: 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.

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.

Recommendations: 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 more information click here. For questions about the recall process, please call Sedgwick at (844) 491-7872.

Report any adverse reactions by calling Sandoz at (800) 525-8747.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Help sustain this vital dissemination of patient safety information with your donations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.