FDA Recall D-1143-2018

Torrent Pharma Inc. · Basking Ridge, NJ

Class II Ongoing 2827 days on record

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

Product

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

Lot / code: Batch: BBY2E001, BBY2D001, BBY2D002

Quantity: 22704 bottles

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Recall record

Recall number: D-1143-2018
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2018-08-17
Classified by FDA Center: 2018-08-28
FDA published: 2018-09-05
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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