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 33342-0

FDA recall notice · announced March 27, 2019 · Macleods Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Notes

Distribution: NJ, NY, FL
Lot/code information: Lot BLM715A, Jul-19
Quantity: 9695 bottles
Status: Terminated
Products in this recall event:
- 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 Pharmaceut (D-1040-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.