Sandoz Inc. has announced an expansion of its voluntary nationwide recall to include one additional lot of Cefazolin for Injection, USP, 1 gram per vial. This decision follows a customer complaint that four vials were mislabeled as Penicillin G Potassium for Injection, USP, 20 million Units but contained Cefazolin for Injection instead.
The company stated there is a reasonable probability that administering cefazolin under the dosing recommendations for penicillin G potassium could lead to serious health consequences. These may include lack of efficacy in treating severe infections and potentially life-threatening allergic reactions.
No adverse events or injuries have been reported so far related to this mislabeling issue. However, Sandoz received a complaint about the administration of the incorrectly labeled product to a patient.
Cefazolin is used to treat bacterial infections and prevent infections before and after surgery. Penicillin G Potassium treats serious infections such as septicemia and pneumonia among others. Both antibiotics belong to the beta-lactam group but are used for different types of infections with differing susceptible organisms.
Sandoz is notifying customers and arranging returns of the recalled product distributed nationwide through select wholesalers. Healthcare providers should stop using this specific lot immediately and contact Sedgwick, Sandoz's Reverse Distributor, for further instructions.
For questions regarding the recall process or reporting adverse reactions, contact information has been provided by Sandoz along with details on how to report issues through FDA’s MedWatch program.
This recall is conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Sandoz emphasizes that forward-looking statements in their release are subject to risks and uncertainties which could affect actual outcomes materially from those expected.
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