Drug Safety Alerts

Vancomycin Voluntary Recall

12/27/2022

On December 27, 2022, the United States Food & Drug Administration (FDA) published a notice of a user-level recall of Vancomycin Hydrochloride Injection, 1.5 g/Vial distributed by Hospira, a Pfizer company. This recall was issued due to two visible glass particulates observed in a single vial.

This recall affects NDCs 00409-3515-11 (vial) & 00409-3515-01 (carton), lot number 33045BA exp. 9/1/2023.

This could be a health hazard or safety risk to patients using product affected by this recall.

According to Hospira/Pfizer, 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. If administered orally or via a nasogastric tube, there may be the potential for gastrointestinal trauma. Hospira/Pfizer further advises that the risk is reduced by the possibility of detection, as the label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

According to Pfizer, it has not received reports of any adverse events related to this recall.

Vancomycin Hydrochloride is an 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. It is used in penicillin-allergic patients, and also for patients who cannot receive or who have failed to respond to other antimicrobials, including penicillin or cephalosporin agents, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobials.

Pfizer is directing doctors with an existing inventory of the lot that is being recalled to discontinue use, stop distribution and quarantine immediately.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Pfizer Medical Information at 1-800-438-1985, option 3, Monday – Friday between 9:00 AM and 5:00 PM (EST) or visit the Pfizer Medication Information web site.

You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit the FDA web site.