Home / Recalls / Torrent Pharma Inc. / D-0122-2020

D-0122-2020 Class II Ongoing

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type
Drugs
Report Date
October 9, 2019
Initiation Date
September 19, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39,432 bottles

Product Description

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10

Reason for Recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021

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