LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668...
FDA Recall #D-0501-2019 — Class II — December 20, 2018
Product Description
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recalling Firm
Torrent Pharma Inc. — Kalamazoo, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
83,016 bottles
Distribution
Nationwide USA and Puerto Rico
Code Information
Count, lots, expiry: [30-count bottle] Lot BO31C016, exp 04/2019; [90-count bottle] Lot BO31C016, exp 04/2019; [1000-count bottle] Lots 4DK3C004, 4DK3C005, exp 04/2019; Lots 4DU3C040, exp 10/2019; Lots 4DU3E049, 4DU3E050, exp 05/2021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated