Reported Apr 17, 2019 · Ongoing
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC:…
Torrent Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torrent Pharma Inc. · 150 Allen Rd Ste 102 · Basking Ridge, NJ · 07920-3856
Is this the product you have?
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg
- a) 30-count (NDC13668-118-30)
- b) 90-count (NDC13668-118-90)
- c) 1000-count (NDC13668-118-10) per bottle , Rx only
- Manufactured byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- ForTorrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
- Lot codes and dates
- Count, lots
- expiry
[30-count bottle] Lot BEF6D038exp 4/30/2020[90-count bottle] Lots BEF6D030BEF6D031exp 4/30/2020Lots BEF6D047BEF6D048BEF6D049BEF6D050BEF6D051exp 7/31/2020Lots BEF6D082BEF6D083BEF6D084BEF6D085BEF6D086BEF6D087exp 10/31/2020Lots 4P04E0034P04E0044P04E0054P04E006exp 1/31/2021[1000-count bottle] 4P04E0074P04E0084P04E009exp 1/31/2021
- Amount recalled
- 173,760 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
This product could cause temporary or reversible health problems — stop using it.
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