Drug product
Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48
D-1320-2016
Product summary
- Event
- Event 73960
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
drug-enforcement:D-1320-2016
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