Why it was recalled
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Product description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10
Lot numbers, UPCs & expiration codes
BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
Where it was sold
Nationwide
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-1459-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 20, 2019
- FDA report date
- Jul 17, 2019
- Quantity
- 142626 bottles (12,836,340 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-1459-2019, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83151
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
- Postal code
- 08536-0009
- Report date
- Jul 17, 2019
- Product type
- Drugs
- Recall number
- D-1459-2019
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 142626 bottles (12,836,340 tablets)
- Termination date
- Oct 26, 2021
- Reason for recall
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2019