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.

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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. 

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