The US Food and Drug Administration (FDA) announces that Legacy Pharmaceutical Packaging, LLC of Earth City, MO is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level and Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level.
Both recalls were prompted due to Camber Pharmaceuticals, Inc and Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).
NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.
Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC numbers associated with Legacy’s product are as follows:
Losartan Potassium, USP, 25mg, NDC 68645-577-54
Losartan Potassium, USP, 50mg, NDC 68645-578-54
Losartan Potassium, USP, 50mg, NDC 68645-494-54
Losartan Potassium, USP, 100mg, NDC 68645-579-54
Please refer to the following two websites in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm633671.htm
http://www.fda.gov/Safety/Recalls/ucm633664.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Currently in Hong Kong, there are 248 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (62 products), losartan (67 products) and olmesartan (17 products). All products are prescription-only medicines.
Regarding impurities in sartan-containing products, a public announcement was first issued on 6 Jul 2018, and letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Jul 2018, 9 Jul 2018, 25 Jul 2018 and 3 Aug 2018. Related news was also previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 6 Jul 2018, with the latest update posted on 15 Mar 2019.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in sartan-containing products, the following 5 valsartan products and 1 irbesartan product were affected and recalled from the Hong Kong market on 6 Jul 2018 and 20 Dec 2018 respectively: HK-61786, HK-61787, HK-61784, HK-61785, HK-60794 and HK-63378. The DH noted that these recalls were completed.
The DH had collected samples of sartan-containing products in the local market for analysis. No NDMA and NDEA were detected.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in losartan, the DH endorsed the recall of 4 losartan products (HK-61932, HK-61933, HK-62634 and HK-62635) from the local market as a precautionary measure due to the potential for NMBA in the products on 11 Mar 2019. The DH will closely monitor the recall.
So far, the DH has received 16 cases of adverse drug reaction related to valsartan, candesartan, irbesartan, losartan and olmesartan. None of them is concluded to be related to the presence of impurities such as NDMA, NDEA and/or NMBA. The DH will keep vigilant on any safety updates on detection of impurities in sartan-containing products issued by overseas regulatory authorities.
Patients who are taking sartan-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals as soon as possible for proper arrangement.
Ends/ Saturday, March 16, 2019
Issued at HKT 12:00
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