The Harvard Drug Group: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Agency Publication Date: August 24, 2017

Affected Products

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

Item# 370010, Lot: 20351701

Lot Numbers:

20351701

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

Item# 370282, Lot: 22941701

Lot Numbers:

22941701

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

Item # 263923, all lots

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

Item # 370339, all lots

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

Item# 370281 all lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77869

Status: Resolved

Manufacturer: The Harvard Drug Group

Manufactured In: United States

Units Affected: 5 products (7,308 bottles; 7,272 bottles; 26,891 bottles; 4,715 bottles; 32,413 bottles)

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Sources: FDA iRES · Raw API Response

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Affected Products

Item# 370010, Lot: 20351701

Lot Numbers:

20351701

Item# 370282, Lot: 22941701

Lot Numbers:

22941701

Item # 263923, all lots

Item # 370339, all lots

Item# 370281 all lots