FDA Recall D-1250-2019

AVKARE Inc. · Pulaski, TN

Class II Ongoing 2577 days on record

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

Product

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

Lot / code: Lot: 19554 Exp. 4/30/2019

Quantity: 846 cartons (42,300 tablets)

Reason for recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Recall record

Recall number: D-1250-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2019-04-24
Classified by FDA Center: 2019-04-28
FDA published: 2019-05-08
Recalling firm: AVKARE Inc.
Firm location: Pulaski, TN

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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