PlainRecalls
FDA Drug Moderate Class II Terminated

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.