Hospira, Inc., Issues Voluntary Nationwide Recall for One Lot of Vancomycin Hydrochloride Injection, USP 1.5 g
On December 22, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-vancomycin-hydrochloride-injection-usp) that Hospira, Inc., a Pfizer company, issued a voluntarily recall of one lot of vancomycin hydrochloride injection, USP, 1.5 g, single-dose flip-top vial, at the consumer level. Hospira, Inc., issued the recall because a report of two glass particulates observed in a single vial.
Hospira, Inc., reported that IV administration of the product could lead to adverse events such as local irritation or swelling, vasculitis or phlebitis, antigenic or allergic reactions, or microvascular obstruction, including pulmonary embolism, and oral or nasogastric administration produces a potential for gastrointestinal trauma. To reduce risk, the company advised that healthcare professionals follow the directions on the label to visually inspect the product for particulate matter and discoloration prior to administration.
To date, Hospira, Inc., has not reported any adverse events related to the recall.
The following product is affected:
|
Product |
NDC |
Lot |
Expiration |
Presentation |
Configuration/ |
|
Vancomycin hydrochloride injection, |
Vial: |
33045BA |
September 1, 2023 |
1.5 g per vial |
10 |
The product was distributed in the United States and Puerto Rico from June 23, 2022–September 19, 2022. Hospira, Inc., said it sent letters to customers who received the recalled product to arrange for return.
Wholesalers, hospitals, institutions, and healthcare professionals with an inventory of the affected lot should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your affected accounts or any additional locations. Hospitals should inform healthcare professionals of the recall. For additional assistance, call Sedgwick, Inc., at 800-805-3093, Monday–Friday from 8 am–5 pm EST, for information on initiating return of the product.
Healthcare professionals with medical questions regarding the recalled product can contact Pfizer Medical Information at 800-438-1985, option three, Monday–Friday, 8 am–5 pm EST. To report adverse events or product concerns, healthcare professionals can contact Pfizer Drug Safety at 800-438-1985, option one, at any time.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.