Why it was recalled
Lack of Sterility Assurance
Product description
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
Lot numbers, UPCs & expiration codes
Lot: 74119EV Exp. 02/01/2019 Lot: 74120EV Exp. 02/01/2019 Lot: 74121EV Exp. 02/01/2019 Lot: 74307EV Exp. 02/01/2019 Lot: 75326EV Exp. 03/01/2019 Lot: 75327EV Exp. 03/01/2019 Lot: 75215EV 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-1046-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 15, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 20,337,650 15 mL single dose vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira a Pfizer Company
Original FDA data
Every field from FDA enforcement report D-1046-2017, 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
- Lot: 74119EV Exp. 02/01/2019 Lot: 74120EV Exp. 02/01/2019 Lot: 74121EV Exp. 02/01/2019 Lot: 74307EV Exp. 02/01/2019 Lot: 75326EV Exp. 03/01/2019 Lot: 75327EV Exp. 03/01/2019 Lot: 75215EV Exp. 03/01/2019
- Postal code
- 27804-8612
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1046-2017
- Classification
- Class II
- Recalling firm
- Hospira a Pfizer Company
- Product quantity
- 20,337,650 15 mL single dose vials
- Termination date
- Jul 20, 2020
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
- 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