The US Food and Drug Administration (FDA) announces that Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to 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.
The affected Losartan Potassium includes 4 repackaged lots numbers (3 initial repackaged lot and 1 expanded repackaged lot) which are listed below:
- Losartan Potassium Tablets USP 50 mg: Legacy lot number: 180190; Expiry: 10/2020
- Losartan Potassium Tablets USP 50 mg: Legacy lot number: 180191; Expiry: 10/2020
- Losartan Potassium Tablets USP 50 mg: Legacy lot number: 181597; Expiry: 02/2021
- Losartan Potassium Tablets USP 50 mg: Legacy lot number: 181598; Expiry: 02/2021
The product can be identified by checking the product name and repackaged lot number on the bottle containing these products. Losartan Potassium was distributed by pharmacies nationwide.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm636624.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Currently in Hong Kong, there are 246 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (62 products), losartan (65 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 23 Apr 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 noted that the recall was completed.
So far, the DH has received 17 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/Thursday, Apr 25, 2019
Issued at HKT 16:00
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