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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
Recall Number D-911-2013
Classification Class III
Code Info Lot 3013002 Exp. 08/14
Product Distributed Qty 10,362 kit cartons
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

Event Detail

Event Id 65676
Product Type Drugs
Status Ongoing
Recalling Firm Braintree Laboratories Inc.
City Holbrook
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwie