In a newspaper advertisement announcing the "URGENT MEDICINE RECALL" of the tablets, the company indicated that it had acted in collaboration with the Medicines Control Council of South Africa."This recall is a precautionary measure following consumer complaints of chipped and broken tablets and inconsistent bottle packaging line clearance practices at our Lincoln, Nebraska facility, which could result in bottles containing foreign tablets, caplets or capsules," the company explained.This is a Class I, Type A recall of the product which contains paracetamol, aspirin and caffeine.Class I is described as "defective-dangerous-potentially life-threatening medicines that predictably or probably could result in serious health risk-adverse events or even death."The company however indicated that the recall was not based on adverse events related to the recalled product, but out of "an abundance of caution".The product is sold in almost 40 countries.In the United States Novartis announced a voluntary recall on January 8. According to Novartis Consumer Health spokesman Senka Hadzimuratovic, the company then identified, reviewed and assessed lots of Excedrin manufactured at the Lincoln facility that were distributed elsewhere.Novartis Consumer Health is not aware of adverse events in South Africa reported with the issues leading to the recall.The local authorities were contacted on January 11 and the recall was issued on January 20.The products should be returned to the pharmacy or store where it was purchased and only tablets in the original manufacturer's bottle will be credited.
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