Class II · ModerateActive recall
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberCount, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019
Where it was soldNationwide USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
| Distributed by / for | Torrent Pharma Inc. |
| NDC | 13668-117-90 |
Show the full FDA record
| Full product label | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda |
| Recalling firm | Torrent Pharma Inc. |
| Distribution | Nationwide USA and Puerto Rico |
| Quantity | 18,852 bottles |
| Recall initiated | 2018-12-20 |
| Report date | 2019-02-27 |
| Recall completed | — |
| Recall number | D-0504-2019 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Kalamazoo MI United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.