Drug product
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
D-316-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 266,900 vials
- Official record key
drug-enforcement:D-316-2013
Official wording
Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Code information: Lot 23-320-DK and 23-321-DK Exp. 11/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility