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Cubicin FDA Alerts

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

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 daptomycin

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

Jul 7, 2020

Audience: Health Professional, Pharmacy

July 7, 2020 -- Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.

Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.

This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:

NDC # Material Description Strength Size Lot No Expiry
67457-813-50 Daptomycin for Injection 500 mg/vial 20 mL vial 7605112 October 2021

Daptomycin for injection is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop use/further distribution or dispensing. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-641-9736 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

Source: FDA

CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

Aug 9, 2014

Audience: Risk Manager, Health Professional, Pharmacy, Nursing

ISSUE: Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials.  Refer to the Press Release for a list of affected products. 

The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.
 
BACKGROUND: CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN was distributed Nationwide to multiple consignees.

RECOMMENDATION:  Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots. 

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:

[08/09/2014 - Press Release - Cubist Pharmaceuticals, Inc.]
[08/09/2014 - Product Labels - FDA]

[08/07/2014 -

Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

Aug 7, 2014

Audience: Pharmacy, Nursing

ISSUE: Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. See the Press Release for a listing of affected lot numbers.

The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

BACKGROUND: Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed nationwide to multiple consignees.

RECOMMENDATION: Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

[08/06/2014 -Press Release - Cubist Pharmaceuticals, Inc.]
[08/07/2014 - Product Labels - FDA]

Cubicin (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter

Apr 18, 2014

Audience: Pharmacy, Patient, Health Professional, Nursing

ISSUE: Cubist Pharmaceuticals, Inc. is voluntarily recalling one lot (Lot # 280453F) of Cubicin (daptomycin for injection) 500 mg to the user level due to the presence of particulate matter, identified as glass particles.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients including: thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

 

BACKGROUND: Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed Nationwide to multiple consignees.

 

RECOMMENDATION: Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot of the product and call Cubist at (855) 534-8309 to arrange for return and replacement of the affected lot.

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

 

[04/18/2014 - Firm Press Release - Cubist Pharmaceuticals, Inc.]

Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots

Aug 29, 2013

Audience: Health Professional, Pharmacy

ISSUE: Cubist has notified customers by letter and phone of the voluntary recall of four lots of Cubicin (daptomycin for injection) due to the presence of particulate matter found in a number of vials from four lots shipped from May 2011 to March 2013.

BACKGROUND: The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.

RECOMMENDATION: Anyone with an existing inventory of the product lots listed in the firm's press release should determine whether they have product from the recalled lots, quarantine and discontinue distribution of all recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EST, Monday through Friday, to arrange for return and replacement of affected lots.

For healthcare professionals and pharmacists with questions regarding this recall may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m. to 5:30 p.m. EST, Monday through Friday.

[08/29/2013 - Firm Press Release - Cubist]

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

Jul 29, 2010

Audience: Infectious Disease, Pulmonology

 

ISSUE:  FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed. 

BACKGROUND: FDA has reviewed published case reports of Cubicin-associated eosinophilic pneumonia and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System. FDA's review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin. Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

RECOMMENDATION: Healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.

 

Cubicin (daptomycin for injection)

Apr 9, 2008

Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers

[Posted 04/09/2008] Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.

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