Drug product
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01
D-1258-2016
Product summary
- Event
- Event 73960
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 bags
- Official record key
drug-enforcement:D-1258-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: All Sterile Compounded Products within Expiry
Distribution pattern: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility