The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0791-2023·Announced 2023-06-07

Cetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations

Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: Class II FDA drug recall with CGMP deviations. No illnesses or injuries reported, and the hazard is theoretical (unverified stability due to inability to complete required studies). Classified as a precautionary recall.

Plain-English summary

Akorn, Inc. is recalling all lots of Cetrorelix Acetate for Injection, 0.25 mg, distributed nationwide in the USA and Puerto Rico. The recall was issued by the FDA due to Current Good Manufacturing Practice (CGMP) deviations.

The company went out of business and could no longer continue the required stability studies for this product. Stability testing is essential to ensure that injected drugs maintain their potency and safety throughout their shelf life. Without completion of these studies, the stability of the product cannot be verified.

Patients who have this medication should consult with their healthcare provider about whether to continue using it. Patients should not stop taking their medication without first talking to their doctor, as this product is used for fertility treatment. Healthcare providers are being notified about this recall.

The recalled product

Product
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only…
Manufacturer
Akorn, Inc.
Category
Drug — Injectable / Fertility
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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