D-911-2013 Class III Terminated
FDA drug recall D-911-2013 was initiated by Braintree Laboratories Inc. on July 15, 2013 and is designated Class III. 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 The recall status is terminated (terminated January 21, 2014). Affected quantity: 10,362 kit cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2013
- Initiation Date
- July 15, 2013
- Termination Date
- January 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,362 kit cartons
Product Description
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 Pattern
Nationwie
Code Information
Lot 3013002 Exp. 08/14