Pfizer’s Hospira Recalls Vancomycin Injection

Hospira, Inc., affiliated to Pfizer Inc., is recalling one lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, citing the presence of visible glass particulates, the U.S. Food and Drug Administration said.

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

The recall involves Vancomycin Injection, USP, Single-Dose Fliptop Vial to the user level with lot 33045BA and expiration date of September 1, 2023. The affected product was distributed to wholesalers/hospitals/ institutions in the United States and Puerto Rico from June 23 through September 19, 2022.

The recall was initiated after two visible glass particulates were observed in a single vial.

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.

In addition, there may be the potential for gastrointestinal trauma if administered orally or via a nasogastric tube.

However, Pfizer has not received reports of any adverse events related to the recall to date.

The label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Wholesalers, hospitals, institutions, and doctors are urged to discontinue use, stop distribution and quarantine the affected product immediately.

In similar recalls, New York -based Hospira in August called back one lot of Propofol Injectable Emulsion (containing benzyl alcohol), due to the potential presence of visible particulates.

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