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Recall Observatory FDA recall evidence

Drug product

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

D-0022-2017

July 15, 2016

Class I

Product summary

Firm
The Harvard Drug Group
Event
Event 74723
Status
Terminated
Classification
Class I
Quantity
153,432 bottles
Official record key
drug-enforcement:D-0022-2017

Official wording

Reason: Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

Code information: 20351407, 20351408, exp 09/16; 20351409, exp 11/16; 20351410, exp 12/16; 20351501, 20351502, exp 01/17; 20351503, exp 03/17; 20351504, exp 04/17; 20351505, exp 05/17; 20351506, 20351507, exp 06/17; 20351508, exp 07/17, 20351509, 20351510, exp 10/17; 20351511, 20351512, 20351513, exp 11/17; 20351601, exp 01/18; 20351602, exp 02/18; 20351603, exp 03/18; 20351604, 20351605, exp 04/18

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination