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
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
See a list of details to help identify the product
Reason 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 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.
Further information is available from AbbVie Medical Information on 1800 043 460.
Details to help identify the product
Supplier running the recall
Identifying numbers
Other identifying numbers
Lot number 1078155 only
Where the product was sold
New South Wales
Queensland
Victoria
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2017/16353 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.