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.