Why it was recalled
Lack of Sterility Assurance
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1049-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 15, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 21,436,700 5mL single dose vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira a Pfizer Company
Original FDA data
Every field from FDA enforcement report D-1049-2017, exactly as published.
Show all FDA fields
- City
- Rocky Mount
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 77533
- Address
- 4285 N Wesleyan Blvd
- Code information
- 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
- Postal code
- 27804-8612
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1049-2017
- Classification
- Class II
- Recalling firm
- Hospira a Pfizer Company
- Product quantity
- 21,436,700 5mL single dose vials
- Termination date
- Jul 20, 2020
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
- Recall initiation date
- Jun 15, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 1, 2017