Among the upwards of 10 million women who experience fertility issues, as estimated in national data, and with around 20,000 each year freezing their eggs based on numbers from UCLA, many know how painstakingly important it is not to ovulate too soon in the days leading up to an egg retrieval.

A Monday report from the U.S. Food and Drug Administration (FDA) reveals a recall by a Chicago-based pharmaceutical company on a trusted drug that prevents that exact situation. From the report, Meitheal Pharmaceuticals, Inc. has recalled 16,477 kits of injectable Cetrorelix Acetate. The dosage affected is 25-milligram (mg) vials for Injection, along with the sterile water for constituting the drug. (Note: Cetrorelix acetate is often colloquially referred to as “Cetrotide” in the field of reproductive medicine, but it’s essential to note that Cetrotide is a brand name by Merck that is not named in this recall.)

National drug codes (NDC) that the FDA says are associated with this recall are the following:

  • NDC 71288-558-90
  • NDC 71288-556-02
  • NDC 71288-557-81

The provided lot information is Q4E0112A, and the affected drugs have a listed expiration date of “30 Apr 2027.” The reason for the recall is stated as: Defective Delivery System: Missing or duplicated needles within the injection kit.

Fortunately, many fertility patients have also learned they can count on the pharmacy to provide surplus needles per appropriate gages for at-home administration. Call your fertility physician or pharmacy with any questions.

The February 23 report highlights that this recall has been classified as a Class II, meaning FDA experts have deemed it “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

But as many patients know: a fertility drug error can lead to massive heartbreak, making advisories like this one critical.

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