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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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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
Distribution Pattern Nationwie

Product Detail

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