Batch recall of four losartan-containing pharmaceutical products (with photos)

     The Department of Health (DH) today (March 11) endorsed a licensed drug wholesaler, Hind Wing Co Ltd (Hind Wing), to recall four products, involving seven batches, containing losartan from the market as a precautionary measure due to the potential for an impurity in the products.
The affected products are:  
Product Hong Kong Registration Number Batch Number
Apo-Losartan Tablets 50mg HK-61932 NK 1253
Apo-Losartan Tablets 100mg HK-61933 NG 2092
NH 5932
NL 1460
Apo-Losartan/HCTZ Tablets 50mg/12.5mg HK-62635 NZ 8848
NL 1441
Apo-Losartan/HCTZ Tablets 100mg/25mg HK-62634 NZ 8845
     Through its surveillance system, the DH noted that Health Canada (the Canadian regulatory authority) is advising that multiple lots of losartan-containing products are being voluntarily recalled because of the potential for an impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). NMBA is a potential human carcinogen.
     Losartan-containing products are prescription medicines used to treat hypertension. According to Hind Wing, the affected batches of the above products have been supplied to private doctors and pharmacies.
     "So far, the DH has not received any adverse reactions related to the above affected products," a DH spokesman said.
     Hind Wing has set up a hotline (2541 5731) to answer related enquiries. The DH will closely monitor the recall.
     The spokesman advises that patients who are taking the above products should not stop taking the medicines, but should seek advice from their healthcare professionals for appropriate arrangement.

Ends/Monday, March 11, 2019
Issued at HKT 20:10