Drug product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
D-0294-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62,650 vials
- Official record key
drug-enforcement:D-0294-2015
Official wording
Reason: Lack of Assurance of Sterility; improperly crimped fliptop vials
Code information: Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility