Berocca Performance Raspberry Blackcurrant (Bayer Australia Ltd)
Product Name
Berocca Performance Raspberry Blackcurrant
Sponsor
ARTG
288146
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
The medicine contains sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to sulfites. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner. Additionally, do not use this medicine because it is past its expiry date.
Review scope
Random
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The label did not include the mandatory declaration for 'sulfites’. Sulfites are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. Whilst the undeclared presence of trace amounts of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions (such as anaphylaxis) due to trace residue of sulfites are rare.
The medicine label was missing the mandatory warning statement 'if symptoms persist, consult your health professional’ in relation to symptoms of stress and mild anxiety. Such statements help to ensure that consumers with unresolved symptoms do not unnecessarily delay access to medical treatment.
However, the last batch of this medicine expired in April 2022 and there is no stock on the market. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.