United States
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. The product was distributed nationwide to wholesalers/hospitals/ institutions in the United States and Puerto Rico from June 23, 2022 through September 19, 2022.
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: Vancomycin Injection, USP, Single-Dose Fliptop Vial
NDC: Vial: 0409-3515-11 Carton: 049-3515-01
Lot Number: 33045BA
Expiration Date: 1SEP2023
Presentation: 1.5 g/Vial
Configuration/Count: 10 units/carton, 10 cartons/case
Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.
Wholesalers, hospitals, institutions, and doctors with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution, and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product.
In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: Vancomycin Injection
Reason of the recall: Presence of Visible Glass Particulates
FDA Recall date: December 27, 2022
Source:
www.fda.gov
