LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottl...
FDA Recall #D-0502-2019 — Class II — December 20, 2018
Product Description
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), 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
65,832 bottles
Distribution
Nationwide USA and Puerto Rico
Code Information
Count, lots, expiry: [30-count bottle] Lot 4L67C035, exp 10/2019; [90-count bottle] Lot 4L67C035, 4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp 11/2019
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated