Drug product
Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
D-1069-2013
Product summary
- Event
- Event 66297
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 vials
- Official record key
drug-enforcement:D-1069-2013
Official wording
Reason: 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.
Code information: Lot 74651-LG4973, Exp 12/4/13
Distribution pattern: NC
Derived failure modes
-
Microbial contamination
microbial contamination
-
Sterility assurance
Lack of Assurance of Sterility