The Ministry of Health wishes to alert the Jamaican public to the recall of drugs containing the active pharmaceutical ingredient valsartan, which is used to treat high blood pressure and heart failure.
The recall has occurred in the wake of an “impurity” detected in the valsartan active substance manufactured by the China-based Zheijing Huahai Pharmaceutical Co. Ltd.
The Standards & Regulation Division in the Ministry of Health have 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.
Denk Pharma GmbH & Co, KG 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, 2018.
The products are:
- Valsar-Denk – 40mg; 80mg; 160 mg; 320 mg;
- Covalsar-Denk – 80/12.5 mg; 160/12.5 mg; 320/12.5 mg;
- Amva-Denk – 10/160; 5/80; 5/160; and
- Amva+HCT-Denk – 5/150/12.5; 10/160/12.5; 10/160/25.
Patients are advised to consult their doctors before discontinuing the use of the drugs. The Ministry of Health will keep the public informed of developments as they occur.