Vancocin HCl Pulvules FDA Alerts

Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates

December 22, 2022 - 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. The product was distributed nationwide to wholesalers/hospitals/ institutions in the United States and Puerto Rico from June 23, 2022 through September 19, 2022.

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. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products.

Risk Statement: Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life- threatening. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall.

The products are used for a variety of indications and are packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars. The affected lots and expiration dates are included in the link listed below. The names and concentration of the drugs are listed in the table following this release.

LINK TO LOT NUMBERS, DISTRIBUTION DATES & DRUG INFORMATION WILL BE ACTIVE ON 12-08-21.

The recall encompasses all compounded sterile and nonsterile drug products, within expiry, that were dispensed from Edge Pharma, LLC. The products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The products can be identified by the label containing the Edge Pharma, LLC name and logo.

Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and direct outreach. Consumers and institutions that have Edge Pharma, LLC products should stop using the products immediately and may either return or discard the recalled lots.

Consumers with questions regarding this recall can contact Edge Pharma, LLC by phone number or e-mail address on Monday-Friday from 8:00 am to 4:00 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq (Vancomycin HCl for Oral Solution) 50 mg/mL Kit Due to a Mix-Up of the Diluent

September 08, 2021 -- Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.

Risk Statement: Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection. To date, Azurity has not received any reports of adverse events related to this recall.

Firvanq® is indicated for use in adults and pediatric patients less than 18 years of age for the treatment of: Clostridium difficile-associated diarrhea and Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). It is packaged as a kit consisting of a bottle with Vancomycin Hydrochloride, USP powder, a bottle of Grape-Flavored diluent, and Full Prescribing Information. The product NDC is 65628-206-05 and the UPC code is 3 65628 206005 1. A total of 2,751 kits of the affected Firvanq®, lot number 21035, with an expiration date of 2022-07-31 were distributed. The product can be identified by its brand name Firvanq®. Product was distributed nationwide through wholesale distributors.

Azurity is notifying its distributors and customers by direct notifications to distributors and via this press release. Azurity is arranging for return and replacement of only recalled products. Consumers, distributors, and retailers that are in possession of Firvanq® from the affected lot should immediately stop using it and return it to the place of purchase. Distributors are asked to place any affected product under quarantine and return it promptly to Azurity.

Consumers with questions regarding this recall may contact Koral Couch, Senior Manager, Customer Service by phone: 781 935-8141 x 119; fax: 781 935-8395 or email: kcouch@azurity.com. Azurity business hours are Monday through Friday from 8:30 am to 5 pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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

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:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

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

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:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[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

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:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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