FDA Recall D-0369-2019

Aurobindo Pharma USA Inc. · East Windsor, NJ

Class II Ongoing 2691 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 tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.

Lot / code: Lot # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot # HVSB17038-A, exp. date 11/2020 Lot # HVSB17039-A, exp. date 11/2020 Lot # HVSB17040-B, exp. date 11/2020 Lot # HVSB18001-A, exp. date 12/2020 Lot # HVSB18002-A, exp. date 12/2020 Lot # HVSB18003-A, exp. date 12/2020 Lot # HVSB18004-A, exp. date 12/2020

Quantity: 53,064 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-0369-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Recall initiated: 2018-12-31
Classified by FDA Center: 2019-01-14
FDA published: 2019-01-23
Recalling firm: Aurobindo Pharma USA Inc.
Firm location: East Windsor, NJ

Drug identification

Brand name(s): VALSARTAN AND HYDROCHLOROTHIAZIDE
Generic name(s): VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer(s): Aurobindo Pharma Limited
NDC(s): 65862-547, 65862-548, 65862-549, 65862-550, 65862-551
Route(s): ORAL

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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