Drug recall D-1461-2019
Product
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10
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.
Lots and codes
BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 145162 bottles (13,064,580 tablets)
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 20, 2019
- Terminated
- October 26, 2021
Related products
- Losartan Potassium and Hydrochlorothiazide – drug information
- NDC 33342-051 Losartan potassium and Hydrochlorothiazide · Losartan Potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-050 Losartan potassium and Hydrochlorothiazide · Losartan Potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-052 Losartan potassium and Hydrochlorothiazide · Losartan Potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 · Macleods Pharmaceuticals Limited