FDA Recall D-0972-2018

Prinston Pharmaceutical Inc · Cranbury, NJ

Class II Ongoing 2862 days on record

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

Product

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09

Lot / code: All lots within expiry.

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0972-2018
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: United States
Recall initiated: 2018-07-13
Classified by FDA Center: 2018-07-20
FDA published: 2018-08-01
Recalling firm: Prinston Pharmaceutical Inc
Firm location: Cranbury, NJ

Drug identification

Brand name(s): VALSARTAN AND HYDROCHLOROTHIAZIDE
Generic name(s): VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer(s): Solco Healthcare US, LLC
NDC(s): 43547-311, 43547-312, 43547-313, 43547-314, 43547-315
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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