Ferring Recalls Bravelle 75 IU Vials Due to Subpotent Drug
Ferring Pharmaceuticals is recalling 32,341 vials of Bravelle 75 IU because the drug was found to be subpotent. The recall is voluntary and nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a common allergen.
Plain-English summary
Ferring Pharmaceuticals Inc. is voluntarily recalling 32,341 vials of Bravelle 75 IU (urofollitropin for injection, purified). The recall was initiated on September 9, 2015, and is classified as Class III by the FDA. The reason for the recall is that the drug was found to be subpotent, meaning it may not contain the full amount of the active ingredient.
The affected product is Bravelle 75 IU, a prescription medication for subcutaneous or intramuscular injection. It is manufactured by Ferring GmbH in Kiel, Germany, for Ferring Pharmaceuticals Inc. in Parsippany, New Jersey. The recall covers specific lots with expiration dates ranging from January 2016 to May 2016, as well as additional lots listed in the recall notice. The distribution was nationwide.
Patients and healthcare providers should check their inventory for the affected lot numbers. If you have this product, you should stop using it and contact your healthcare provider or Ferring Pharmaceuticals for instructions on how to return the product. The recall status is currently terminated.
The recalled product
- Product
- Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for…
- Manufacturer
- Ferring Pharmaceuticals Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 32,341
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #'s: K11813A-1
- K11813A-2
- Exp 01/16
- K11813B-1
- K11813C-1
- Exp 04/16
- K13031A-1
- K13031B-1
- K13031B-2
- Exp 05/16 additional lots added: H14942A-1
- H14941A-2. H18815A-1
- H15815B-1
- H15815SMA-1
- H16998A-1
- H16998SMA-1
- K10008A-1
- K10008A-2
- K13503SMA-1
- K13503A-1
- K13503B-1
Distribution
Distributed nationwide across the United States.
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