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vancomycin FDA Alerts

The FDA Alert(s) below may be specifically about vancomycin or relate to a group or class of drugs which include vancomycin.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for vancomycin

Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter

Aug 31, 2017

Audience: Pharmacy, Infectious Disease

ISSUE: Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

In the event the particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. The risk is reduced by the possibility of detection. The label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

BACKGROUND: Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Vancomycin Hydrochloride USP, 750 mg/vial NDC: 0409-6531-02, Lot 632153A, Expiry Date 01 MAR 2018, is packaged in a carton containing 10 units. The lot was distributed from August 2016 through January 2017 nationwide in the United States and Puerto Rico.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[08/30/2017 - Press Release - Hospira]

Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial

Jan 25, 2017

Audience: Pharmacy

ISSUE: Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States.

If particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.

BACKGROUND: Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[01/24/2017 - Press Release - FDA]

Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit

Oct 8, 2014

Audience: Pharmacy, Nursing, Health Professional

ISSUE: Hospira, Inc. issued a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015. The product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer.

This recall is being carried out to the medical facility/retail level (both human and veterinary).

BACKGROUND: There have been no adverse events or complaints reported for the affected lot.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle.

For additional assistance, call Stericycle at 1-844-861-6215 between the hours of 8am to 5pm ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[10/07/2014 - Press Release - Hospira, Inc.]

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