FOLLTROPIN Injectable Kits Recalled for Particulates

Vetoquinol USA, Inc. has announced a recall of six lots of FOLLTROPIN Injectable Kits for cattle due to the presence of particulate matter in the sterile diluent vial. This recall affects products distributed nationwide in the U.S.

Affected Products:

• FOLLTROPIN Injectable Kits with specific lot numbers: 5105788, 5105798, 5105808, 5105819, 7170599, and 5105829.
• Each kit includes a 20 mL vial of Folltropin lyophilized FSH powder and a 20 mL vial of sterile bacteriostatic saline diluent.

Reason for Recall:

The recall was initiated because particulate matter was found in the sterile diluent vials during routine inspections. The presence of particulates can lead to injection site reactions or hypersensitivity in cattle.

Health Risks:

Possible adverse reactions include pain, swelling, decreased activity, fever, and labored breathing. No adverse events have been reported to date.

Consumer Action:

• Stop using the affected product immediately.
• Quarantine the recalled kits and contact Vetoquinol USA, Inc. for instructions on returning or disposing of the product.
• For questions, contact Vetoquinol USA, Inc. at 1-800-267-5707, Monday through Friday, 8 a.m. to 5 p.m. CST.
• Report any adverse reactions to the FDA at 1-888-FDA-VETS or online.