Lucrin Depot Paediatric 30 mg PDS (leuprorelin acetate)

Recall – potential for incomplete delivery of medication

29 September 2017

Consumers and health professionals are advised that AbbVie, in consultation with the TGA, is recalling one lot of Lucrin Depot Paediatric 30 mg PDS due to a quality issue.

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

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. Even so there is the possibility that the affected product could still be administered. If the contents of the syringe are injected it could result in the incomplete delivery of medication and in the patient receiving a sub-therapeutic dose. It could also result in increased irritation or reaction at the injection site.

The affected lot number is 1078155. No other lots are affected by this recall.

photo of product packaging

The affected lot number is 1078155. The lot number is displayed on the left side of the front panel of the packs (highlighted with a red oval).

Information for consumers

If you, or somebody you provide care for, is taking Lucrin Depot Paediatric 30mg PDS please be alert to this issue.

Check any pre-filled syringes that you have and if they are from lot number 1078155 please 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.

Should you require further information, contact AbbVie Medical Information on 1800 043 460.

Information for health professionals

The affected lot was released for supply to the Australian market on 2 August 2017 and AbbVie has written to pharmacists and specialists regarding this issue.

Where you deem appropriate, we would ask that you contact the carers of patients to inform them of this recall. There are other lots of Lucrin Depot Paediatric 30 mg PDS available. No other lot is affected by this recall.

If affected stock is returned to a pharmacy, contact the wholesaler to organise return and credit, following their return procedure.

Should you require further information, please contact AbbVie Medical Information on 1800 043 460.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.