Last Updated on October 15, 2024 by The Health Master
NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Fliptop Vial, lot 33045BA, to the user level due to two visible glass particulates 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.
If administered orally or via a nasogastric tube, there may be the potential for gastrointestinal trauma.
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.
To date, Pfizer 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.
The NDC, Lot Number, Expiration Date, and Configuration details for Vancomycin HCl for injection, USP are indicated below.
| Product | NDC | Lot Number | Expiration Date | Presentation | Configuration/ Count |
|---|---|---|---|---|---|
| Vancomycin Injection, USP, Single- Dose Fliptop Vial | Vial: 0409-3515-11 Carton: 0409-3515-01 | 33045BA | 1SEP2023 | 1.5 g/Vial | 10 units/carton, 10 cartons/case |
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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