Drug product
Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41
D-1284-2016
Product summary
- Event
- Event 73960
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
drug-enforcement:D-1284-2016
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