Class I Recall for Antibiotic Injection

Hospira Inc, a Pfizer company, is voluntarily recalling 89,700 vials of vancomycin hydrochloride injection. According to the February 1, 2023, US Food and Drug Administration (FDA) Enforcement Report, glass particulates were observed in a vial. The FDA categorized the recall Class I, which warns use of the affected product could cause serious adverse health consequences or death.

“If administered intravenously, patients may experience adverse events such as local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism,” Hospira stated in a December 27, 2022, company announcement. “If administered orally or via a nasogastric tube, there may be the potential for gastrointestinal trauma.”

The recall affects vancomycin hydrochloride for injection, 1.5 g/vial, single-dose flip-top vial (NDC 0409-3515-11), 10 vials per carton (NDC 0409-3515-01), from lot 33045BA (Exp. 9/1/23). The vials were distributed throughout the United States and in Puerto Rico between June 23, 2022, and September 19, 2022.

Hospira initiated the recall December 22, 2022. The FDA designated the recall Class I on January 25, 2023.

Vancomycin hydrochloride is a prescription antibiotic indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin structure infections.