Drug 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

D-1458-2019

June 20, 2019

Class II

Product summary

Firm: Macleods Pharma Usa Inc
Event: Event 83151
Status: Terminated
Classification: Class II
Quantity: 4277 bottles (4,277,000 tablets)
Official record key: drug-enforcement:D-1458-2019

Official wording

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information: BLI710A Nov 2019

Distribution pattern: Nationwide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations