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. 

See a list of details to help identify the product

Reason 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/

Details to help identify the product

Who sold the product

Hospitals and pharmacies

Dates available for sale

-

Where the product was sold

New South Wales
Queensland
South Australia
Tasmania
Victoria
Western Australia
Northern Territory

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2022/19626 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.