On February 23, 2011, the FDA published a nationwide recall of 6,434 Q-Cap cartons of Bravelle. Apparently, Ferring Pharmaceuticals, Inc. received several complains that sale units of Bravelle contained inner cartons mislabeled as Menopur – a different Ferring infertility drug. The Menopur cartons were imprinted with the correct lot number for the inner carton assembly of Bravelle and contained the correct lot of Bravelle vials. Ferring initiated a recall by telephone (Jan 7, 2011) and by letter (Jan 19, 2011). Manufacturer Draxis Specialty Pharmaceutical Inc. also initiated a recall of the drug. (fda.gov)
Question
** 2015 RECALL INFO ** – I just got off the phone with Ferring (manufacturer) and my local pharmacist. According the the Ferring rep I spoke with, this is a “pharmacy-level” recall (whatever that means. Pharmacist didn’t even know what that was) so maybe that’s why no info is showing up on the FDA. Supposedly there was a notification sent out to pharmacies in August and then another recent one last week. Again, according to the rep I spoke with, Ferring is recalling all of the Bravelle product because some were found to be less potent than they should be, ie – an efficacy problem. The Ferring rep told me that consumers were not notified because it is not a hazard and that anyone with Bravelle should go ahead and use it (consult doctor) but that there would be no more available on the market. I didn’t think to ask how long it would be before any it is produced or sold again, so maybe never. The Reddit thread cited here mentions Follistim and Gonal-F as possible alternatives or replacements for anyone using Bravelle.
I was told this is a “Class II” recall and involved all product nationwide. Hope that helps. If anyone has anything else to add, I’m eager to hear it.
posted on October 15, 2015
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no manufacturer warning information available for this drug.
1.1 Induction of Ovulation in Women who have Previously Received Pituitary Suppression
Prior to initiation of treatment with BRAVELLE®:
1.2 Development of Multiple Follicles as Part of an Assisted Reproductive Technology (ART) Cycle in Ovulatory Women Who Have Previously Received Pituitary Suppression
Prior to initiation of treatment with BRAVELLE®:
BRAVELLE® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH is a gonadotropin and consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
BRAVELLE® is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of BRAVELLE® contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 International Units of FSH. BRAVELLE® contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in BRAVELLE®. When stored at 3° to 25°C, up to 40% of the α-subunits may be oxidized.
The in vivo biological activity of urofollitropin for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Urofollitropin), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.
FSH is a glycoprotein that is acidic and water-soluble.
BRAVELLE® has been mixed in vitro with MENOPUR® with no evidence of aggregation.
Therapeutic class: Infertility