Tuesday 25 September, 2018

Contaminated heart failure, high blood pressure drug recalled

Several drugs used to treat high blood pressure and heart failure have been withdrawn from the local market over concerns that they have been contaminated according to the Ministry of Health.

The ministry, in a statement on Friday, said the drugs that have been recalled contain the active pharmaceutical ingredient valsartan. The ministry said the recall was initiated after an “impurity” was detected in the valsartan active substance manufactured by the China-based Zheijing Huahai Pharmaceutical Company Limited.

It said its Standards & Regulation Division has indicated that of the 18 valsartan-containing products registered for use in Jamaica, only the products marketed from Denk Pharma GmbH & Co KG were found to obtain their active pharmaceutical ingredient from the China-based company.

The health ministry said company initiated a voluntary recall of stocks containing valsartan from the trade to the retail level, in a letter received from their local distributor, Massy Distribution on July 9.

The recalled products are:

Valsar-Denk - 40mg; 80mg; 160 mg; and 320 mg.

Covalsar-Denk - 80/12.5 mg; 160/12.5 mg; and 320/12.5 mg.

Amva-Denk - 10/160; 5/80; and 5/160.

Amva+HCT-Denk - 5/150/12.5; 10/160/12.5; and 10/160/25.

Patients are advised to consult their doctors before discontinuing the use of the drugs. The ministry said it will keep the public informed of developments as they occur. 

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