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High RiskFDAfda-D-1016-2022OTHER

Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01

Units Affected
15
Recall Date
April 13, 2022
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1016-2022.

cGMP deviations: Temperature abuse

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1016-2022.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1016-2022.

Mckesson Medical-Surgical Inc. Corporate Office

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

How to report to FDAFile a report at FDA

Mckesson Medical-surgical Inc. Corporate Office Recall FAQ

Mckesson Medical-surgical Inc. Corporate Office is the subject of an injectable drugs safety report: Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01. The notice was published on April 13, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 15 units are potentially affected.