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 /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
Lot numbers, UPCs & expiration codes
Lot BEF7D051
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-0123-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 19, 2019
- FDA report date
- Oct 9, 2019
- Quantity
- 17,088 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0123-2020, 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 BEF7D051
- Postal code
- 07920-3856
- Report date
- Oct 9, 2019
- Product type
- Drugs
- Recall number
- D-0123-2020
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 17,088 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 /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
- 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