The Recall Desk

FDA (Drugs) recall action 84127

Perrigo Company PLC recalled 17 products on 2020-03-25

The FDA (Drugs) publishes a recall like this one as 17 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 17 pages.

Products
17
Announced
2020-03-25
Critical
0
Units
—

Why these products were recalled

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

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

1–17 of 17

  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer (Ranitidine 75 mg) tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC
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    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo is recalling Maximum Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Regular Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchang
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    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-
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    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Regular Strength Acid Reducer (Ranitidine) tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; ND
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    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential Impurity Contamination

    Perrigo is recalling specific lots of Maximum Strength Acid Reducer ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pha
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 3680
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
    Category
    Distribution
    0 states