FDA Recall D-0984-2018

Teva Pharmaceuticals USA · North Wales, PA

Class II Ongoing 2859 days on record

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

Product

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19

Lot / code: Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M

Quantity: 64,168 bottles

Reason for recall

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

Recall record

Recall number: D-0984-2018
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Recall initiated: 2018-07-16
Classified by FDA Center: 2018-07-24
FDA published: 2018-08-01
Recalling firm: Teva Pharmaceuticals USA
Firm location: North Wales, PA

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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