FDA Recall D-1054-2019

Rising Pharmaceuticals, Inc. · Saddle Brook, NJ

Class II Ongoing 2625 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 Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90

Lot / code: 472180005B, exp. date 02/29/2020 472180011A, exp. date 04/30/2020 472180012A, exp. date 04/30/2020

Quantity: 35,281 bottles

Reason for recall

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Recall record

Recall number: D-1054-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
Recall initiated: 2019-03-07
Classified by FDA Center: 2019-03-21
FDA published: 2019-03-27
Recalling firm: Rising Pharmaceuticals, Inc.
Firm location: Saddle Brook, 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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