FDA Recall D-1114-2019

Torrent Pharma Inc. · Basking Ridge, NJ

Class II Ongoing 2632 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, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Lot / code: Count, lots, expiry: [90-count bottle ] Lots 4DU1E005, 4DU1E006, 4DU1E008, exp 1/31/2021; Lots 4DU1E007, exp 1/31/2021

Quantity: 133,992 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-1114-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and Puerto Rico
Recall initiated: 2019-02-28
Classified by FDA Center: 2019-04-10
FDA published: 2019-04-17
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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