Sandoz Inc. has initiated a voluntary recall of one lot of Cefazolin for Injection, USP, 1 gram per vial due to a packaging error. A customer complaint revealed that four vials labeled as Penicillin G Potassium for Injection were mistakenly included in the carton intended for Cefazolin.
The potential risks associated with administering Penicillin G Potassium instead of Cefazolin include serious and possibly life-threatening health consequences such as lack of efficacy, antibiotic resistance, adverse reactions, severe allergic reactions including anaphylaxis, drug interactions, cardiac arrhythmias from high potassium levels particularly in patients with kidney impairment, and delayed recovery.
Sandoz has not received any reports of adverse events or injuries related to this recall so far but did receive a complaint about the incorrect administration of the product.
Cefazolin is used to treat bacterial infections in various parts of the body and can also be used prophylactically before and after surgery. It is indicated for adults, elderly individuals, pediatric patients, including newborns. In contrast, Penicillin G Potassium is prescribed for certain serious infections such as septicemia and skin infections among others. Although both antibiotics belong to the beta-lactam group, they have different indications and susceptible organism spectrums.
Customers are being notified by letter regarding the recall and Sandoz is arranging for the return of the affected product shipped nationwide. Healthcare providers and customers should cease using this specific lot immediately and contact Sedgwick at (844) 491-7872 or via email at Sandoz6004@sedgwick.com.
For inquiries related to the recall process or reporting adverse reactions, contact Sedgwick at (844) 491-7872 during business hours or Sandoz at (800) 525-8747. Adverse reactions can also be reported through the FDA's MedWatch program online or by mail/fax.
This recall has been conducted with approval from the U.S. Food and Drug Administration.
