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TGA warning on substandard vitamin capsules
The Therapeutic Goods Administration (TGA) has ordered a consumer level recall of 38 bottles of Vital brand Vitamin B complex capsules because the folate content of the products is one tenth of the strength that is marked on the bottles.
Vital Health Foods Australia Pty Ltd of NSW advised the TGA in late October that they had found one batch of their vitamin B complex, which had been labelled as containing 400 micrograms of folic acid (folate), to only contain around 40 micrograms of folate.
After finding the mistake the company contacted all of its retail outlets and has advised the TGA that they have located and recalled all of the product except for 38 bottles which had been sold to consumers.
The TGA is very concerned about the breach because many women of child-bearing age and those who are pregnant often take the recommended dose of 400 micrograms or more of folate supplement a day to assist in the prevention of birth defects of the brain or spinal cord such as neural tube defects.
While the capsules in question are not specifically indicated for the prevention of neural tube defects, the label states supplementation is recommended 'whenever the body is low in nutrients and when bodily needs are increased such as during stress, pregnancy, dieting and exercise'.
The recalled product is one batch of Vital Vitamin B Complex (Aust L 79284), batch number 0300693, which is labelled as containing 400 micrograms per capsule of folic acid when it only contains 40 micrograms per capsule.
Each bottle contains 50 capsules with a recommended daily dose of one capsule per day.
While there are only 38 bottles involved the TGA has ordered the company to conduct an urgent consumer recall including advertising the recall action in major newspapers in every State and Territory.
The TGA urges consumers to check their vitamin B complex supplements to ensure that they are not taking any of the affected Vital products.
Media contact: Kay McNiece, Media Adviser, TGA 0412 132 585