AbbVie Pty Ltd — Lucrin Depot Paediatric leuprorelin acetate 30mg for injection, prefilled dual chamber syringe (single dose)

PRA number


Published date

Product description

One lot only - 1078155. The lot number is displayed on the left side of the front panel of the packs (see image).
Expiry 31/12/2019
Supplied from 2 August 2017

Lucrin Depot Paediatric 30mg PDS is used to treat central precocious puberty, a condition causing children to enter puberty prematurely.

AUST R: 218936
leuprorelin acetate 30mg PDS
Identifying features

Other identifying numbers

Lot number 1078155 only

Reasons the product is recalled

Potential for incomplete delivery of medication.

The batch is being recalled due to reports of the active ingredient powder not dissolving sufficiently with the diluent liquid in the syringe, causing clumping. The clumping is readily visible to the naked eye in affected products and should be noticed on inspection.

The hazards to consumers

If the contents of the syringe are injected, it could result in the incomplete delivery of medication and the patient receiving a sub-therapeutic dose. Injection of affected medication could also result in increased irritation or reaction at the injection site.

What consumers should do

If you, or somebody you care for, is taking Lucrin Depot Paediatric 30mg PDS, please be alert to this issue. Check any prefilled syringes that you have and if they are from lot number 1078155, return them to your pharmacy for refund or replacement. All pre-filled syringes should be routinely inspected before use and if you notice anything unusual, consult a health professional.

Further information is available from AbbVie Medical Information on 1800 043 460.

Where the product was sold

New South Wales

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category