Recalls / Class II
Class IID-1049-2017
Product
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
- Affected lot / code info
- a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383EV Exp. 03/01/2019 b.) 25 vial carton: Lot: 7538EV; Exp 03/01/2019
Why it was recalled
Lack of Sterility Assurance
Recalling firm
- Firm
- Hospira a Pfizer Company
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 4285 N Wesleyan Blvd, N/A, Rocky Mount, North Carolina 27804-8612
Distribution
- Quantity
- 21,436,700 5mL single dose vials
- Distribution pattern
- U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Timeline
- Recall initiated
- 2017-06-15
- FDA classified
- 2017-08-01
- Posted by FDA
- 2017-08-09
- Terminated
- 2020-07-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1049-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.