| TGA Action ID |
RC-2020-RN-00470-1 |
| Type of Product |
Medicine |
| Product Name/Description |
TACROLIMUS APOTEX tacrolimus 0.5 mg capsule blister pack
Batch: 19122305
Expiry Date: 06/2021
ARTG 209273 |
| ARTG Number |
209273 |
| Action Type |
Product Defect Correction |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
Pharmacor received a market complaint which identified that inside a 100s carton pack, 1 out of the 2 sealed tri-laminated pouches (each containing 5 blister sheets x 10 caps) had inadvertently been labelled as 1 mg.
Both pouches are printed with the same batch number with no signs of tampering.
The reporting pharmacist confirmed that all blister sheets from both pouches were correctly labelled as 0.5 mg, and the individual capsules are correctly marked with “0.5 mg” and “Tacro” as per its approved product description. |
| Instructions for Customers/Users |
Pharmacists are asked to inspect the pouches in every carton of Tacrolimus Apotex 0.5mg capsules x 100, batch 19122305 prior to dispensing. This inspection can also be conducted well in advance in the event Pharmacies happen to hold units of this particular batch on the dispensary shelf.
Any unit carton which contains one or more pouches labelled Tacrolimus Apotex 1mg, or any other anomaly, ought not be dispensed in the first instance and should be set aside prior to return to Apotex.
Alternatively, in a rural or remote setting or in a unique situation of patient inconvenience, Pharmacists may choose to still make the supply ensuring the patient is adequately counselled and suitably reassured regarding this typographical anomaly, as their professional discretion dictates, on a case-by-case basis, considering each patients full circumstances.
There are no quality, safety or efficacy issues with the capsiules themselves.
This action has been closed out on 01/12/2020 |
| Action Commencement Date |
28/05/2020 |
| Responsible Entity |
|
| Contact Information |
Apotex Customer Service on 1800 276 839 or email customer.service.aus@apotex.com.au |