Drug recall D-1460-2019
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 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 33342-051-10
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
BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 29106 bottles (2,619,540 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