Recalls / Class II
Class IID-1046-2017
Product
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
- Affected lot / code info
- 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
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
- 20,337,650 15 mL 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-1046-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.