Vetoquinol FOLLTROPIN Injectable Kits for Cattle recalled due to Particulate matter, USA

United States

Vetoquinol USA, Inc. is recalling six lots of FOLLTROPIN® (porcine pituitary-derived follicle stimulating hormone for injection) Kits, due to the presence of particulate matter in the sterile diluent vial. The product was marketed by veterinary distributors nationwide in the U.S.

Particulates were observed during routine examination of retained samples of the sterile diluent vials for the following lots:

- Kit: 510578
- Diluent Lot #: 840915
- Expiration Date: 5/31/2026
- Distribution Begin Date: 08/30/2023
- Distribution End Date: 10/23/2023

- Kit: 510579
- Diluent Lot #: 844585
- Expiration Date: 5/31/2026
- Distribution Begin Date: 10/23/2025
- Distribution End Date: 11/06/2023

- Kit: 510580
- Diluent Lot #: 844583
- Expiration Date: 5/31/2026
- Distribution Begin Date: 11/06/2023
- Distribution End Date: 06/18/2024

- Kit: 510581
- Diluent Lot #: 934975
- Expiration Date: 1/31/2027
- Distribution Begin Date: 06/18/2024
- Distribution End Date: 12/13/2024

- Kit: 717059
- Diluent Lot #: 934976
- Expiration Date: 1/31/2027
- Distribution Begin Date: 06/09/2025
- Distribution End Date: 10/28/2025

- Kit: 510582
- Diluent Lot #: 934973
- Expiration Date: 1/31/2027
- Distribution Begin Date: 12/13/2024
- Distribution End Date: 06/09/2025

Risk Statement: The administration of an injectable product that contains particulate matter may result in injection site reaction or hypersensitivity reaction in response to the foreign material. Some possible clinical signs of an adverse event include pain and/or swelling/wounds at the injection site, as well as decreased activity level, fever, and/or labored breathing. If you observe any of these or any other concerning signs in an animal that may have been administered this product, please contact a veterinarian as soon as possible. To date, no adverse event reports have been received for the listed batches.

About Folltropin: Folltropin is a porcine pituitary-derived follicle stimulating hormone approved in the US for intramuscular injection for the induction of superovulation in beef and dairy heifers and cows. Folltropin is a prescription product in the U.S.

The Folltropin Kit consists of one 20 mL vial of Folltropin lyophilized FSH powder and one 20 mL vial of sterile bacteriostatic saline diluent. The Folltropin Kit is labeled with a lot number on the outside of the carton. The Folltropin powder and the sterile diluent are each labeled with a separate lot number on their respective vials.

Vetoquinol USA, Inc. has not identified any issues with the Folltropin powder vial. Folltropin is also sold as a Dual Pack (contains two vials of Folltropin FSH powder) which is not impacted by the recall because it contains no diluent vials.

The particulate matter was discovered during routine annual inspection of retain samples of the sterile diluent vials. Customers who have received FOLLTROPIN Kits from the batches impacted by this recall should stop using the product immediately and quarantine product subject to recall. Please contact Vetoquinol USA, Inc. for further instructions for returning or disposal of the recall product.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vetoquinol-usa-inc-recalls-six-lots-folltropin-injectable-kits-cattle-due-presence-particulate