Status
Terminated
Drug Enforcement D-911-2013
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
Classification
Class III
Report Date
August 28, 2013
Termination Date
January 21, 2014
Product Information
- Product description
- Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
- Product quantity
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwie
Location & Firm
- Recalling firm
- Braintree Laboratories Inc.
- Address
-
270 Centre St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-911-2013
- Event ID
- 65676
- Recall initiation date
- July 15, 2013
- Center classification date
- August 20, 2013
- Code info
- Lot 3013002 Exp. 08/14
- More code info
- —