Recalls / Class II
Class IID-316-2013
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
- Brand name
- Sodium Acetate
- Generic name
- Sodium Acetate
- Active ingredient
- Sodium Acetate Anhydrous
- Route
- Intravenous
- NDC
- 0409-7299
- FDA application
- NDA018893
- Affected lot / code info
- Lot 23-320-DK and 23-321-DK Exp. 11/14
Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 266,900 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-02-26
- FDA classified
- 2013-05-06
- Posted by FDA
- 2013-05-15
- Terminated
- 2014-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-316-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.