Vetoquinol USA, Inc. Recalls Six Lots of FOLLTROPIN Injectable Kits for Cattle Due to Presence of Particulate Matter in Sterile Diluent Vial
Vetoquinol USA, Inc., Fort Worth, TX, 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.
Particulates were observed during routine examination of retained samples of the sterile diluent vials for the following lots:
| Kit Lot # | Diluent Lot # | Expiration Date | Distribution Begin Date | Distribution End Date |
|---|---|---|---|---|
| 510578 | 840915 | 5/31/2026 | 08/30/2023 | 10/23/2023 |
| 510579 | 844585 | 5/31/2026 | 10/23/2025 | 11/06/2023 |
| 510580 | 844583 | 5/31/2026 | 11/06/2023 | 06/18/2024 |
| 510581 | 934975 | 1/31/2027 | 06/18/2024 | 12/13/2024 |
| 717059 | 934976 | 1/31/2027 | 06/09/2025 | 10/28/2025 |
| 510582 | 934973 | 1/31/2027 | 12/13/2024 | 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.