The Recall Desk

FDA (Drugs) recall action 82326

Legacy Pharmaceutical Packaging LLC recalled 3 products on 2019-03-27

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-03-27
Critical
0
Units
5,805,872

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Drugs)··2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 100 mg, due to the presence of the impurity N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 100 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 68645-579-54
    Category
    Distribution
    5 states
  • SevereFDA (Drugs)··2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 25 mg, because an impurity was detected. The recall involves 456,732 bottles distributed by Wal-Mart.

    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
    Category
    Distribution
    5 states
  • SevereFDA (Drugs)··2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, due to the presence of an impurity, N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 50 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 68645-578-54
    Category
    Distribution
    5 states