Hospira’s Vancomycin Injection recall: reason, affected lots, and all you need to know

Hospira, Inc., has issued a nationwide Vancomycin Injection recall over concerns about the presence of glass particulates in the vials. New York-based Hospira Pharma is affiliated with international pharmaceutical corporation Pfizer Inc.

The voluntary recall was initiated after the discovery of two visible glass particulates in a single vial of the Vancomycin Hydrochloride Injection. The products under the Vancomycin Injection recall fall in the category of Powders for injection (PIs) drugs and are distributed in 'powder' form in vials.

Vancomycin Hydrochloride is a popular antibiotic drug that is used to treat serious to severe infections caused by susceptible strains of methicillin-resistant staphylococci. The antibiotic drug is also effective in treating other infections, including staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin-structure infections.

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All you need to know about Vancomycin Injection recall

The recalled Vancomycin Hydrochloride drugs were distributed to wholesalers, hospitals, and other medical institutions across the United States and Puerto Rico between June 2022 and September 19, 2022. Since the drug was meant to be used by doctors and other medical professionals, it was not distributed to stores that could retail it to the general public.

The recall affects one lot of Vancomycin Hydrochloride Injections, USP, Single-Dose Fliptop Vial. The products under the Vancomycin Injection recall carry the lot number 33045BA, and have an expiration date of September 1, 2023, printed on them.

Product	NDC	Lot Number	Expiration Date	Presentation	Configuration/Count
Vancomycin Injection, USP, Single-Dose, Fliptop Vial	Vial: 0409-3515-11 Carton: 049-3515-01	33045BA	1SEP2023	1.5 g/Vial	10 units/carton, 10 cartons/case

Wholesalers have been urged to stop the distribution of the recalled drugs right away. Hospitals, medical institutions, and doctors will also discontinue the use of the recalled drugs for the treatment of any patient immediately. All stocks of the affected product are to be quarantined with immediate effect to ensure the safety of patients across the country.

recalled vial of Vancomycin Hydrochloride Injection (Image via FDA)

Medical professionals with doubts and queries related to the Vancomycin Injection Recall can contact Pfizer Medical Information at 1-800-438-1985 (choose option 3) between 9 am to 5 pm ET, Monday through Friday. If you want to report an adverse effect of the drug or have a complaint, you can get in touch with Pfizer Drug Safety at 1-800-438-1985 (choose option 1), 24 hours a day, 7 days a week.

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What are the risks related to the Vancomycin Injection recall

Though Pfizer has not received any reports of adverse events related to the Vancomycin Injection recall, it is important to understand the medical risks related to it. If the Vancomycin Hydrochloride Injection is administered intravenously, it can lead to the patient experiencing adverse effects, including irritation or swelling, vasculitis, phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.

Some medical cases often require an oral or nasogastric tube administration of the Vancomycin Hydrochloride drug, which may put the patient at risk of experiencing gastrointestinal trauma if the said drug contains any unwanted matter, like glass particulates.

The silver lining to the problem is that the label on the vials under the Vancomycin Injection Recall carries a disclaimer or warning statement. The statement asks the healthcare professional to visually inspect the vial for any unwanted particulate matter or discoloration prior to the administration of the drug to the patient, thus reducing the risk of the administration of the affected drugs to the patient.