Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
Lot numbers, UPCs & expiration codes
Lot BLM715A, Jul-19
Where it was sold
NJ, NY, FL
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-1040-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 21, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 9695 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-1040-2019, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82147
- Address
- 666 Plainsboro Rd
- Address (line 2)
- Bldg 200 Ste 230
- Code information
- Lot BLM715A, Jul-19
- Postal code
- 08536-3030
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1040-2019
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 9695 bottles
- Termination date
- Sep 28, 2020
- Reason for recall
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
- Distribution pattern
- NJ, NY, FL
- Recall initiation date
- Feb 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2019