PRA number
Published date
Product description
Dasatinib Dr. Reddy's dasatinib 50 mg film coated tablet blister pack
Batch No. ZH20021 (50mg); Product Code: 36456
Expiry date: 06/2023
Dasatinib Dr. Reddy's dasatinib 100 mg film coated tablet blister pack
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)
Prescription only medicine for for the treatment of chronic myeloid leukaemia (CML). It is also used to treat a particular form of acute lymphoblastic leukaemia (ALL) called Philadelphia chromosome positive or Ph+ ALL.
Reasons the product is recalled
The tablet may not dissolve properly and this can result in incomplete release of the medicine.
The hazards to consumers
If patients receive a lower dose of the medicine than prescribed, the medicine may be less effective, increasing the risk of serious adverse health effects.
What consumers should do
Consumers should check whether their medicine is from the affected batches and contact their pharmacist or healthcare provider to make arrangements to return the product for a refund.
Do not stop or alter your prescribed treatment. Make an appointment with your physician to discuss alternative treatment options.
For more details, see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01209-1
For further information, contact Dr. Reddys Laboratories Australia by phone on
0427 306 107 or via the website at https://www.drreddys.com/australia/contact-us/
Traders who sold this product
Hospitals and pharmacies
Where the product was sold
Dates available for sale
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.