Medicine recalls
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| The United States: Vetoquinol USA, Inc. recalls six lots of FOLLTROPIN Injectable Kits for cattle due to presence of particulate matter in sterile diluent vial |
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The US Food and Drug Administration (FDA) announces that Vetoquinol USA, Inc. is recalling six lots of FOLLTROPINĀ® (porcine pituitary-derived follicle stimulating hormone for injection) Kits (Kit lot number: 510578, 510579, 510580, 510581, 717059, 510582), 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.
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 any of these or any other concerning signs is observed 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.
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. Vetoquinol USA, Inc. has not identiļ¬ed any issues with the Folltropin powder vial.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vetoquinol-usa-inc-recalls-six-lots-folltropin-injectable-kits-cattle-due-presence-particulate
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 11 Nov 2025.
Ends/Wednesday, Dec 3, 2025
Issued at HKT 15:30
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