TGA alert on a consumer level recall of a complementary medicine - Nature's Own Zinc + B6 Magnesium

Media statement

5 May 2004

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), advises consumers that Mayne Consumer Products is conducting a consumer level recall of some batches of its product Nature's Own Zinc + B6 Magnesium.

This product is primarily used for the relief of PMS symptoms, including breast tenderness, nervous tension, tiredness, bloating and mild fluid retention, and for the relief of symptoms associated with agitation, confusion, anxiety and restlessness.

Due to a manufacturing error the product contains more zinc than is indicated on the label and is also incorrectly labelled about the daily dose.

The label states that each tablet contains 5.7 milligrams of zinc and has a recommended daily dose of three tablets. The product is being recalled because each tablet in these batches contains 30 milligrams, which results in a daily dose of 90 milligrams.

The TGA is concerned about the extent of the mislabelling which understates the quantity of zinc in the product by more than five times that indicated on the label.

The TGA believes, however, there is not a risk of serious illnesses to consumers who may have taken the tablets.

Consumers who have purchased the affected batches of this medicine need to be aware that they are prescription strength and return the medicine to place of purchase for a refund.

This product can be identified by AUST L 28196 located on the label. It is packaged in green plastic bottles of 75 and 200 tablets. Affected Batch numbers are 302614, 302846, and 400080.

MEDIA CONTACT: KAY MCNIECE, MEDIA ADVISER, TGA, 0412 132 585

Top of page