Status
Terminated
Drug Enforcement D-1068-2013
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Classification
Class II
Report Date
October 9, 2013
Termination Date
April 23, 2025
Product Information
- Product description
- Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
- Product quantity
- 54 Vials
- Reason for recall
- Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- NC
Location & Firm
- Recalling firm
- Triangle Compounding
- Address
-
3700 Regency Pkwy Ste 140
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1068-2013
- Event ID
- 66297
- Recall initiation date
- September 6, 2013
- Center classification date
- September 30, 2013
- Code info
- Lot #814748-LG14917, Exp 10/31/13
- More code info
- —