July 2013 FDA Recall Drug by Braintree Laboratories Inc.
D-911-2013 - Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder

This Class III drug recall was voluntarily initiated by Braintree Laboratories Inc. on July 15, 2013 for the product Drug. The FDA reported the reason for recall as defective container; small micro fracture observed in the 2-liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder. The product was distributed in Nationwie and the recall is currently terminated.

Recall Number: D-911-2013

Reason for Recall
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Initiated
07-15-2013
Reported
08-28-2013
Quantity
10,362 kit cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65676
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Braintree Laboratories Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwie
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-21-2014
Product Description About Product Description
Full technical description of the product.
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02

Batch or Lot Expiration Information

Lot# Lot 3013002 Exp. 08/14