Drug recall D-1459-2019
Product
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
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
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
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 142626 bottles (12,836,340 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