FDA Recall D-1263-2019

Legacy Pharmaceutical Packaging LLC · Earth City, MO

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, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

Lot / code: Lot 181598; 02/2021

Quantity: 60,012 bottles

Reason for recall

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Recall record

Recall number: D-1263-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: TN, AZ
Recall initiated: 2019-04-24
Classified by FDA Center: 2019-05-01
FDA published: 2019-05-08
Recalling firm: Legacy Pharmaceutical Packaging LLC
Firm location: Earth City, MO

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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