FDA Recall D-0505-2019

Torrent Pharma Inc. · Kalamazoo, MI

Class II Ongoing 2702 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 and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

Lot / code: Count, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020

Quantity: 18,780 bottles

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.

Recall record

Recall number: D-0505-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and Puerto Rico
Recall initiated: 2018-12-20
Classified by FDA Center: 2019-02-15
FDA published: 2019-02-27
Recalling firm: Torrent Pharma Inc.
Firm location: Kalamazoo, MI

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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