The Food and Drug Administration (FDA) is warning patients and healthcare professionals not to use stolen lots of the fertility medications Gonal-f RFF Redi-ject (follitropin alfa injection; EMD Serono) and Gonal-f Multi-Dose (follitropin alfa injection; EMD Serono).
Over 16,000 packages were stolen in Italy on May 17, 2018, and were intended to be shipped to the US. The affected products have the following lot numbers:
- Gonal-f RFF Redi-ject 450 IU (0.75mL) – Lot# BA049137 – Exp 5/31/2019
- Gonal-f Multi-Dose 1050 IU – Lot# BA040937 – Exp 9/30/2019
- Gonal-f Multi-Dose 450 IU – Lot# BA049143 – Exp 2/29/2020
- Gonal-f Multi-Dose 450 IU – Lot# BA049040 – Exp 9/30/2019
The alert states that anyone who has received suspicious offers to buy Gonal-f products since May 17, 2018 should contact the FDA Office of Criminal Investigations.
Healthcare professionals and patients should check Gonal-f products for possible tampering before use; purchases should only be made through licensed wholesale distributors and pharmacies. In addition, adverse events related to these agents should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Gonal-f and Gonal-f RFF Redi-ject contain follicle-stimulating hormones intended to develop multiple follicles in ovulatory patients undergoing assisted reproductive technology, and to induce ovulation and pregnancy in patients with functional anovulatory infertility without primary ovarian failure.
For more information call (888) 463-6332 or visit FDA.gov.