July 2016 FDA Recall Drug by The Harvard Drug Group
D-0022-2017 - Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

This Class I drug recall was voluntarily initiated by The Harvard Drug Group on July 15, 2016 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products; positive findings of burkholderia cepacia. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0022-2017

Reason for Recall
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Initiated
07-15-2016
Reported
10-19-2016
Quantity
153,432 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74723
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-27-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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