Drug product

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

D-1114-2019

February 28, 2019

Class II

Product summary

Firm: Torrent Pharma Inc.
Event: Event 82585
Status: Ongoing
Classification: Class II
Quantity: 133,992 bottles
Official record key: drug-enforcement:D-1114-2019

Official wording

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Code information: Count, lots, expiry: [90-count bottle ] Lots 4DU1E005, 4DU1E006, 4DU1E008, exp 1/31/2021; Lots 4DU1E007, exp 1/31/2021

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

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

impurity, N-Methylnitrosobutyric acid (NMBA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations