Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
Reported: October 9, 2013 Initiated: September 6, 2013 #D-1069-2013
Product Description
Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
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.
Details
- Recalling Firm
- Triangle Compounding
- Units Affected
- 8 vials
- Distribution
- NC
- Location
- Cary, NC
Frequently Asked Questions
What product was recalled? ▼
Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.. Recalled by Triangle Compounding. Units affected: 8 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2013. Severity: Moderate. Recall number: D-1069-2013.
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