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
FDA recall notice · announced December 17, 2014 · Hospira
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Lack of Assurance of Sterility; improperly crimped fliptop vials
Notes
Distribution: Nationwide
Lot/code information: Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61
Quantity: 62,650 vials
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.