FDA recall D-911-2013

Braintree Laboratories Inc. · Class III · drug

Product

Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02

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

Distribution

Nationwie

Key facts

Status: Terminated
Initiation date: 2013-07-15
Report date: 2013-08-28
Termination date: 2014-01-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Holbrook, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-911-2013