Medication Recall – Important Notice

OA/RA capsules: Recall due to contamination

23rd January 2019

Consumers and health professionals are advised that Blueskygreenearth, in consultation with the TGA, is recalling OA/RA capsules (batch 17098003) due to contamination with a substance that poses an unacceptable risk to health. This product has also been withdrawn from the Australian market and will no longer be available for supply.

OA/RA is an Ayurvedic product that is indicated for temporary pain relief of osteoarthritis (OA) and rheumatoid arthritis (RA).

TGA testing has found that the currently available batch of the product is contaminated with very low levels of aristolochic acid.

Aristolochic acid is included in Schedule 10 to the Poisons Standard, which lists substances considered to pose an unacceptable risk to health. There is no established safe exposure level to aristolochic acids, which have been linked to kidney problems and urinary tract cancers.

Information for consumers

If you or someone you provide care for takes OA/RA capsules, please be alert to this issue and discontinue use immediately. The product should not be consumed.

If you have any OA/RA capsules, the remaining product can be returned to the place of purchase for a refund.

If you have any questions or concerns about this issue, talk to your health professional or contact 1300 133 807

Information for health professionals

Please be aware of the above issue and advise patients regarding alternative treatment options if they seek advice.

If you have any questions or concerns about this issue, contact 1300 133 807.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.