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 0.96 parts per million.
Product description
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
Lot numbers, UPCs & expiration codes
Lot #: B0517068-101618, Exp. Date: 10/2019
Where it was sold
Product was distributed to Florida.
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-1270-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2019
- FDA report date
- May 8, 2019
- Quantity
- 44 HDPE bottles of 90 = 3,960 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1270-2019, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 82748
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: B0517068-101618, Exp. Date: 10/2019
- Postal code
- 15701-3571
- Report date
- May 8, 2019
- Product type
- Drugs
- Recall number
- D-1270-2019
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 44 HDPE bottles of 90 = 3,960 tablets
- Termination date
- May 19, 2020
- 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 0.96 parts per million.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
- Distribution pattern
- Product was distributed to Florida.
- Recall initiation date
- Apr 22, 2019
- Initial firm notification
- Letter
- Center classification date
- May 2, 2019