D-1069-2013 Class II Terminated
FDA drug recall D-1069-2013 was initiated by Triangle Compounding on September 6, 2013 and is designated Class II. 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 recall status is terminated (terminated April 23, 2025). Affected quantity: 8 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 9, 2013
- Initiation Date
- September 6, 2013
- Termination Date
- April 23, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 vials
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.
Distribution Pattern
NC
Code Information
Lot 74651-LG4973, Exp 12/4/13