| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01209-1 |
| Product Name/Description |
DASATINIB DR. REDDY'S dasatinib 50 mg film coated tablet blister pack
DASATINIB DR.REDDY'S dasatinib 100 mg film coated tablet blister pack
Batch No. ZH20021 (50mg); Product Code: 36456
Expiry date: 06/2023 and
Batch No. ZH20023 (100mg); Product Code: 36458
Expiry date: 12/2023
ARTG 337451
(DASATINIB DR.REDDY'S dasatinib 50 mg film coated tablet blister pack)
ARTG 337460
(DASATINIB DR.REDDY'S dasatinib 100 mg film coated tablet blister pack) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/10/2022 |
| Responsible Entity |
|
| Reason/Issue |
Dr Reddy's has observed out of specification results in dissolution test of Dasatinib 50 mg (Batch ZH20021) and 100 mg (Batch ZH20023) tablets during stability testing at 3 months long term stability (30?C/75% RH) sample analysis.
Failure in the dissolution test can result in incomplete release of the medicine and lack of efficacy.
This issue does not affect any other batches of Dasatinib Dr.Reddy’s Tablets or any other Dr.Reddy’s products. These batches have been distributed to hospitals and pharmacies since March 2022.
To date, there have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Dr. Reddy's are advising retailers and wholesalers to immediately quarantine Dasatinib 50 mg (Batch ZH20021) and 100 mg (Batch ZH20023) tablets on site to prevent further use.
Pharmacists and healthcare providers are requested to contact patients who have been provided affected stock to arrange return. A copy of the customer letter should be provided from healthcare providers to impacted patients.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0427 306 107 - Mark - Dr. Reddy's |