Recall Enforment Report D-0022-2017

Drug Recall Enforcement Report Class I voluntary initiated by The Harvard Drug Group, originally initiated on 07-15-2016 for 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 The product was recalled due to microbial contamination of non-sterile products; positive findings of burkholderia cepacia. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	74723 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0022-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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
Reason For Recall	Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	153,432 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	10-19-2016
Recall Initiation Date	07-15-2016 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-27-2017 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	The Harvard Drug Group
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.