FDA Recall D-1265-2019

Torrent Pharma Inc. · Basking Ridge, NJ

Class II Ongoing 2583 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, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Lot / code: Count, lots, expiry: [90-count bottle] Lots 4DU2D005, 4DU2D006, exp 12/31/2019; Lots 4DU2D026, 4DU2D027, 4DU2D029, exp 3/31/2020; Lot 4DU2E007, exp 12/31/2020; [1000-count bottle] Lot 4DU2D017, exp 2/29/2020, Lots 4DU2D025, 4DU2D028, exp 3/31/2020; Lots 4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047, 4DU2D048, exp 8/31/2020; Lot BDK2E001, exp 12/31/2020; Lots 4DU2E042, 4DU2E044, exp 2/28/2021; Lots BDK2E012, BDK2E013, exp 8/31/2021

Quantity: 164,424 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.

Recall record

Recall number: D-1265-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide USA and Puerto Rico
Recall initiated: 2019-04-18
Classified by FDA Center: 2019-05-01
FDA published: 2019-05-08
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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