Drug recall D-1458-2019
Product
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
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
BLI710A Nov 2019
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 4277 bottles (4,277,000 tablets)
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 20, 2019
- Terminated
- October 26, 2021
Related products
- Losartan potassium – drug information
- NDC 33342-045 Losartan potassium · Losartan Potassium 50 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-044 Losartan potassium · Losartan Potassium 25 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-046 Losartan potassium · Losartan Potassium 100 mg/1 · Macleods Pharmaceuticals Limited