The Recall Desk

FDA (Drugs) recall action 77869

The Harvard Drug Group recalled 5 products on 2017-08-30

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2017-08-30
Critical
0
Units
78,599

Why these products were recalled

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia 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.

1–5 of 5

  • SevereFDA (Drugs)··2017-08-30

    Rugby Diocto Syrup Recalled for Microbial Contamination

    The Harvard Drug Group is recalling Rugby Diocto Syrup due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-08-30

    Rugby Senexon Liquid Recalled for Microbial Contamination

    The Harvard Drug Group is recalling Rugby Senexon Liquid due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-08-30

    Rugby Diocto Liquid Recalled for Microbial Contamination

    The Harvard Drug Group is recalling Rugby Diocto Liquid due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-08-30

    Rugby Aller-chlor Syrup Recalled for Microbial Contamination

    The Harvard Drug Group is recalling 4,715 bottles of Rugby Aller-chlor syrup due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-08-30

    Major Senna Syrup Recalled for Microbial Contamination

    The Harvard Drug Group is recalling Major Senna Syrup due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09
    Category
    Distribution
    0 states