The Recall Desk

FDA (Drugs) recall action 83200

Geritrex, LLC recalled 8 products on 2019-07-31

The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2019-07-31
Critical
0
Units
56,871

Why these products were recalled

cGMP Deviations: Products may have microbial contamination.

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.

1–8 of 8

  • SevereFDA (Drugs)··2019-07-31

    Geritrex Recalls Diphenhydramine Oral Liquid Due to Potential Microbial Contamination

    Geritrex, LLC is recalling 8,645 bottles of Diphenhydramine Oral Liquid due to cGMP deviations that may result in microbial contamination.

    Product
    Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-31

    Geritrex Recalls Gericare Diocto Liquid Stool Softener Due to Microbial Contamination Risk

    Geritrex, LLC is recalling 6,165 bottles of Gericare Diocto Liquid Stool Softener due to cGMP deviations that may result in microbial contamination.

    Product
    Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-31

    Geritrex Recalls Ritussin DM Due to Potential Microbial Contamination

    Geritrex, LLC is recalling Ritussin DM Double Strength cough syrup due to cGMP deviations that may result in microbial contamination.

    Product
    Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-31

    Geritrex Recalls Ritussin DM Due to Potential Microbial Contamination

    Geritrex, LLC is recalling 5,107 bottles of Ritussin DM Children & Adults due to cGMP deviations that may result in microbial contamination.

    Product
    Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-31

    Gericare Geri-Tussin DM Recalled for Potential Microbial Contamination

    Geritrex, LLC is recalling Gericare Geri-Tussin DM due to cGMP deviations that may result in microbial contamination.

    Product
    Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-31

    Geritrex Recalls Preferred Plus Dioctyl Liquid Stool Softener Due to Microbial Contamination

    Geritrex, LLC is recalling Preferred Plus Dioctyl Liquid Stool Softener due to cGMP deviations that may result in microbial contamination.

    Product
    Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-07-31

    Gericare Iron Supplement Elixir Recalled for Potential Microbial Contamination

    Geritrex, LLC is recalling Gericare Iron Supplement Elixir due to cGMP deviations that may have resulted in microbial contamination.

    Product
    Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-31

    Geritrex Recalls Iron Elixir Due to Potential Microbial Contamination

    Geritrex, LLC is recalling Preferred Plus Pharmacy Iron Elixir due to cGMP deviations that may result in microbial contamination.

    Product
    Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16
    Category
    Distribution
    0 states