The Recall Desk

FDA (Drugs) recall action 83871

Apotex Inc. recalled 6 products on 2019-11-20

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2019-11-20
Critical
0
Units
1,844,672

Why these products were recalled

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

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.

1–6 of 6

  • SevereFDA (Drugs)··2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to Possible NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 1,132,453 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Possible NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-20

    Apotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk

    Apotex Inc. is recalling Walgreens Maximum Strength Wal-Zan 150 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-20

    Apotex Recalls Walgreens Wal-Zan 75 Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Walgreens Regular Strength Wal-Zan 75 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 162,344 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
    Category
    Distribution
    0 states