[5/30/2018] FDA is alerting health care professionals, patients, and the drug supply chain of stolen injectable fertility medications, Gonal-f RFF Redi-ject (follitropin alfa injection) and Gonal-f Multi-Dose (follitropin alfa injection). Patients who have product with the lot numbers below should not use them.
All product with these lot numbers were in this stolen shipment. The lot numbers are located on the flap of each box, below the tamper-proof seal and next to the 2D barcode:
|Product 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 products were stolen in Italy on May 17, 2018, and were intended to be shipped to the United States. EMD Serono Inc. of Rockland, Massachusetts, reported the theft of more than 16,000 packages of Gonal-f RFF Redi-ject and Gonal-f Multi-Dose to FDA on May 18, 2018.
Drug supply chain stakeholders that receive or possess these lot numbers must notify FDA via Form FDA 3911. Anyone who has received suspicious or unsolicited offers to purchase Gonal-f products since May 17, 2018, should contact FDA Office of Criminal Investigations at 800-551-3989.
Drug supply chain stakeholders should continue to remain vigilant when buying or selling Gonal-f and check the lot number to prevent stolen product from entering the drug supply chain.
Patients, health care professionals, and drug supply chain stakeholders should check the product and label for signs of tampering before using. FDA also reminds health care professionals, patients, and drug supply chain stakeholders to purchase products only from licensed wholesale distributors and pharmacies. See FDA’s Know Your Source and BeSafeRx programs for more information.
FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drug products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.