FDA Recall D-0022-2017

The Harvard Drug Group · Livonia, MI

Class I — life-threatening Terminated 255 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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

Quantity: 153,432 bottles

Reason for recall

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

Recall record

Recall number: D-0022-2017
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2016-07-15
Classified by FDA Center: 2016-10-12
FDA published: 2016-10-19
Terminated: 2017-03-27
Recalling firm: The Harvard Drug Group
Firm location: Livonia, MI

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