Ferring Inc. Canada, in consultation with Health Canada, would like to inform health care professionals of a voluntary recall of four (4) lots of BRAVELLE™. The recall is due to reduced potency of the product detected during routine stability testing. It is unlikely that a reduced therapeutic effect would cause a direct adverse health consequence in the short term. However, there is the potential for unnecessary over-exposure of patients in establishing an effective dose. If there is a shortage of BRAVELLE, the treating fertility physician should use their discretion and should weigh the benefits and risks of using another product or defer therapy until the supply resumes. For patients who have not yet started on BRAVELLE there are other options for treatment with FSH. FSH products available on the market are not deemed interchangeable.
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