FDA Recall D-0121-2020

Torrent Pharma Inc. · Basking Ridge, NJ

Class II Ongoing 2429 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10

Lot / code: Lot 4DU2E009

Quantity: 8,688 bottles

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.

Recall record

Recall number: D-0121-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide USA and Puerto Rico
Recall initiated: 2019-09-19
Classified by FDA Center: 2019-10-02
FDA published: 2019-10-09
Recalling firm: Torrent Pharma Inc.
Firm location: Basking Ridge, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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