Novarel FDA Alerts

Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance

October 10, 2019 -- Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.

The affected products are injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. Products were distributed to both customers and/or medical facilities. A full list of the affected products with the applicable lot numbers and expiration dates is as follows:

The pharmacy has notified potentially affected customers of the voluntary recall via U.S. Mail and direct outreach. Customers who have received sterile compounded products subject to the voluntary recall should not use them and return the product to the pharmacy for a full refund.

Consumers with questions regarding this recall can contact Innoveix Pharmaceuticals, Inc. by phone 800-370-1910 or innoveix@gmail.com. We are available Monday through Friday from 9 AM to 4:30 PM CST. 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.

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

HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

[Posted 02/15/2017]

ISSUE: Synergy Rx Pharmacy recalled all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician offices and clinics in Arizona, California, Wisconsin, and Minnesota.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

BACKGROUND: Human Chorionic Gonadotropin (HCG) is an unapproved product marketed for weight loss. The product is packaged in 15 mL serum glass vials bearing a label that includes Synergy Rx Pharmacy’s name and expiration date. All lots of these products are affected. Synergy Rx Pharmacy has not received any reports of adverse events, to date, related to this recall.

RECOMMENDATION: Synergy Rx Pharmacy is notifying its customers by phone and is arranging for return of all recalled products. Customers that have the recalled product should immediately stop using it and contact the help line to arrange for the return of any unused product.

Customers with questions regarding this recall can contact Synergy Rx Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm Pacific Time Zone, at 619-821-8224.

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

[02/14/2017 - Press Release - Synergy Rx Pharmacy]

HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance

ISSUE: Talon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. Administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.

The sterile products were distributed to patients and providers nationwide between January 18 and July 18, 2016.

BACKGROUND: The recalled lots were packaged in 10ml amber glass vials bearing a label containing the name and strength of the drug, the lot number and the beyond-use date.

RECOMMENDATION: Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Providers who have dispensed any lyophilized HCG or sermorelin to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall. Talon is asking all patients and providers that received lyophilized HCG and sermorelin compounded products from TCP between January 18 and July 18, 2016, and that remain within expiry, to take the following actions:

• Discontinue use of the products;
• Quarantine any unused product until further instructions are received on how to return the product; and
• Contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at talonrecall@gmail.com to discuss the return of any unused lyophilized HCG and/or sermorelin.

Customers with questions regarding this recall can contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at talonrecall@gmail.com.

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