Inspections, Compliance, Enforcement, and Criminal Investigations

May 31, 2018: Notification of Stolen Fertility Drugs: Gonal-f® RFF Redi-ject® and Gonal-f® Multi-Dose

EMD Serono, Inc. of Rockland, Massachusetts is working with the U.S. Food and Drug Administration (FDA), Office of Criminal Investigations (OCI), the Italian Medicines Agency (AIFA), and other law enforcement officials to recover cases of select lots of prescription Gonal-f® RFF Redi-ject® (follitropin alfa injection) and Gonal-f® Multi-Dose (follitropin alfa injection), which are injectable fertility medications that are stored refrigerated and room temperature, respectively. On May 17, 2018, a delivery truck containing the products was hijacked near Bari, Italy, while en route for shipment to the United States. This product’s trademark has been registered with U.S. Customs, who have been alerted to the possibility of illicit shipments into the U.S.
 

The stolen truck contained 16,457 packages of Gonal-f® RFF Redi-ject® and Gonal-f® Multi-Dose. All of the lot numbers associated with the product stolen are exclusive to this specific shipment. Lot numbers of the stolen products are listed in Table 1 below. The lot numbers can be found on the flap of each box, below the tamper-proof seal and next to the 2D barcode.
 

Table 1
 NAME NDC LOT EXPIRATION DOSAGE FORM
  Gonal-f® RFF Redi-ject® 450 IU (0.75 mL)  44087-1116-1  BA049137  5/31/2019  Liquid for injection
  Gonal-f® Multi-Dose 1050 IU  44087-9070-1  BA049037  9/30/2019  Vial powder with diluent for injection
  Gonal-f® Multi-Dose 450 IU  44087-9030-1  BA049143  2/29/2020  Vial powder with diluent for injection
  Gonal-f® Multi-Dose 450 IU  44087-9030-1  BA049040  9/30/2019  Vial powder with diluent for injection

These lot numbers are not valid for the United States and therefore should be deemed suspect product.  
 

Anyone who may be in possession of these lots should NOT use them and should report the suspect product to EMD Serono by calling 1-888-398-4567 or email us at us.customerservice@emdserono.com.  Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for Gonal-f® RFF Redi-ject® and Gonal-f® Multi-Dose after the date of the theft, should contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or to visit the OCI Web Site

EMD Serono recommends that consumers always inspect the product and label for signs of tampering or contamination prior to use. Gonal-f® RFF Redi-ject® and Gonal-f® Multi-Dose are packaged in "tamper-evident" cartons, meaning that if the package has been opened, it will be evident to the consumer. Consumers can also use EMD Serono’s Check My Meds™ app to scan the 2D barcode on the packaging to verify the authenticity of the serial number on the medication. Consumers, pharmacists and other healthcare professionals should report any evidence of suspected product tampering to EMD Serono by calling 1-888-398-4567 or email us at us.customerservice@emdserono.com. This information should also be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program

EMD Serono advises customers and consumers to always purchase product only from licensed distributors and pharmacies to ensure that the product has not deviated from the authorized supply chain (which excludes online pharmacies). For consumer inquiries about a specific product, please call EMD Serono at 1-888-398-4567 or email us at us.customerservice@emdserono.com

Pharmacies, other healthcare professionals and patients who may be in possession of these lots should NOT use them. If these lots are accidentally used, healthcare professionals and patients are encouraged to report such use, and any adverse events, side effects, or product quality problems related to such use to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online
  • 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

All Gonal-f® RFF Redi-ject® and Gonal-f® Multi-Dose products with lot numbers other than those listed in the table above meet the standards of quality for distribution and use by patients.

EMD Serono has taken quick and appropriate actions to ensure the safety of its products and will continue to work closely with law enforcement, the FDA, the AIFA, and distribution partners to maintain the integrity of the supply chain.

Page Last Updated: 05/31/2018
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