| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2017-RN-01201-1 |
| Product Name/Description |
Lucrin Depot Paediatric acetate 30mg for injection, prefilled dual chamber syringe
(1 single dose)
Batch Number: 1078155
Expiry: 31/12/2019
AUST R: 218936 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
AbbVie has received complaints regarding an issue with a single batch (1078155) of Lucrin Depot Paediatric in which the active ingredient powder is not suspending sufficiently with the diluent liquid in the syringe. The usually free flowing powder with the syringe, (before the diluent is added) has been reported as “clumped” or “caked”. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbvie is recalling all units of the batch. Wholesalers and pharmacists are being advised directly. Users will be advised through their paediatrician.
For further information, please see https://www.tga.gov.au/alert/lucrin-depot-paediatric-30-mg-pds-leuprorelin-acetate
This action has been closed out on 19/09/2018 |
| Contact Information |
1800 043 460 - Abbvie Medical Information Hotline |