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 of 9.82 parts per million.
Product description
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
Lot numbers, UPCs & expiration codes
Lot 4DU2E009
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-0121-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 19, 2019
- FDA report date
- Oct 9, 2019
- Quantity
- 8,688 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0121-2020, exactly as published.
Show all FDA fields
- City
- Basking Ridge
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 83840
- Address
- 150 Allen Rd Ste 102
- Code information
- Lot 4DU2E009
- Postal code
- 07920-3856
- Report date
- Oct 9, 2019
- Product type
- Drugs
- Recall number
- D-0121-2020
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 8,688 bottles
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Sep 19, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 2, 2019