ROTARIX

Q: Is this product safe to consume?

No. This product has been recalled due to: Irregularities in the manufacturing process were detected, leading to possible insufficient filling of the last 50 oral applicators of the Rotarix batch, meaning failure to meet quality requirements for the volume parameter. Potential effects: lack of vaccination efficacy.

Irregularities in the manufacturing process were detected, leading to possible insufficient filling of the last 50 oral applicators of the Rotarix batch, meaning failure to meet quality requirements for the volume parameter. Potential effects: lack of vaccination efficacy.

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Risk Level

High

Manufacturer

GlaxoSmithKline Biologicals S.A. Belgia

Recall Date

22.03.2019

What You Should Know

Recommendations

Do not use product from batch AROLC214AE; patients and caregivers should check the batch number, return the product to the pharmacy or doctor, and consult a physician about the need for re-vaccination...

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw the medicinal product Rotarix batch AROLC214AE from the market throughout the country and granted the decision immediate enforceability; the mark...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: Irregularities in the manufacturing process were detected, leading to possible insufficient filling of the last 50 oral applicators of the Rotarix batch, meaning failure to meet quality requirements for the volume parameter. Potential effects: lack of vaccination efficacy.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Check the official report for specific batch details.

ROTARIX

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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