Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
Count, 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 sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0504-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 20, 2018
- FDA report date
- Feb 27, 2019
- Quantity
- 18,852 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0504-2019, exactly as published.
Show all FDA fields
- City
- Kalamazoo
- State
- MI
- Status
- Ongoing
- Country
- United States
- Event ID
- 81838
- Address
- 1803 Whites Rd Ste 1
- Code information
- Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019
- Postal code
- 49008-2883
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0504-2019
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 18,852 bottles
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Dec 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2019