Published recall report · ImpurityUpdated · 7 yr ago
Torrent Pharma Inc. recall: Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
- Producer
- Torrent Pharma Inc.
4DU3E009
- Dates on pack
- Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021
4DU3D018
- Dates on pack
- Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021
More detail
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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