FDA Recall D-1048-2019

Legacy Pharmaceutical Packaging LLC · Earth City, MO

Class II Ongoing 2631 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, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54

Lot / code: Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20

Quantity: 456,732 bottles

Reason for recall

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Recall record

Recall number: D-1048-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Wal-Mart distribution centers in AR, CA, GA, IN and MD
Recall initiated: 2019-03-01
Classified by FDA Center: 2019-03-21
FDA published: 2019-03-27
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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