Drug product

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

D-911-2013

July 15, 2013

Class III

Product summary

Firm: Braintree Laboratories Inc.
Event: Event 65676
Status: Terminated
Classification: Class III
Quantity: 10,362 kit cartons
Official record key: drug-enforcement:D-911-2013

Official wording

Reason: 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

Code information: Lot 3013002 Exp. 08/14

Distribution pattern: Nationwie

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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