Drug recall: Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution…
Class II FDA enforcement event 77533. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Sterility Assurance
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Hospira a Pfizer Company started this drug recall on 15 Jun 2017. The firm address in the FDA record is in Rocky Mount, NC. FDA put the recall in Class II. FDA event 77533 has 4 product records. The first FDA enforcement report date is 9 Aug 2017. The record gives the status Terminated, with the termination date 20 Jul 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Recalling firm
Hospira a Pfizer Company, Rocky Mount, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1046-2017 | 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 | 20,337,650 15 mL single dose vials | Class II | Terminated | 9 Aug 2017 |
| D-1047-2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02 | 91,483,150 50 mL single dose vials | Class II | Terminated | 9 Aug 2017 |
| D-1048-2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25). | 15,034,600 10 mL multiple dose use vials | Class II | Terminated | 9 Aug 2017 |
| D-1049-2017 | 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 | 21,436,700 5mL single dose vials | Class II | Terminated | 9 Aug 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2017
- 343
- Share of these events in Class II
- 57%
- Product records in this event
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-1046-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 77533. https://recallregister.com/fda/ii/77533/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
- What quantity of product is in FDA event 77533?
- The event has 4 product records. The first record gives this quantity:
20,337,650 15 mL single dose vials
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2017 have the same class?
- 57% of the 343 drug events that started in 2017 are in Class II.