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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77533

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 15, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hospira a Pfizer Company

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

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

D-1046-2017
Recall number
D-1046-2017
Initiated
June 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Hospira a Pfizer Company
Quantity
20,337,650 15 mL single dose vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

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

Distribution pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

drug · product 2 of 4

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

D-1047-2017
Recall number
D-1047-2017
Initiated
June 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Hospira a Pfizer Company
Quantity
91,483,150 50 mL single dose vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

Code information

Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019, Lot: 73230EV Exp. 01/01/2019, Lot: 73231EV Exp. 01/01/2019, Lot: 73232EV Exp. 01/01/2019, Lot: 73233EV Exp. 01/01/2019, Lot: 73234EV Exp. 01/01/2019, Lot: 73235EV Exp. 01/01/2019, Lot: 73236EV Exp. 01/01/2019, Lot: 73298EV Exp. 01/01/2019, Lot: 74058EV Exp. 02/01/2019, Lot: 74104EV Exp. 02/01/2019, Lot: 74105EV Exp. 02/01/2019, Lot: 74106EV Exp. 02/01/2019, Lot; 74107EV Exp. 02/01/2019, Lot: 74197EV Exp. 02/01/2019, Lot: 74198EV Exp. 02/01/2019, Lot: 74199EV Exp. 02/01/2019, Lot: 74200EV Exp. 02/01/2019, Lot: 74201EV Exp. 02/01/2019, Lot: 75171EV Exp. 03/01/2019, Lot: 75172EV Exp. 03/01/2019, Lot: 75173EV Exp. 03/01/2019, Lot: 75174EV Exp. 03/01/2019, Lot: 75175EV Exp. 03/01/2019, Lot: 75176EV Exp. 03/01/2019, Lot: 75177EV Exp. 03/01/2019, Lot: 75178EV Exp. 03/01/2019. Lot: 75293 Exp. 03/01/2019, Lot: 75418EV Exp. 03/01/2019, Lot: 75419EV Exp. 03/01/2019

Distribution pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

drug · product 3 of 4

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).

D-1048-2017
Recall number
D-1048-2017
Initiated
June 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Hospira a Pfizer Company
Quantity
15,034,600 10 mL multiple dose use vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

Code information

a.) one vial Lot: 74393EV Exp. 05/01/2018 Lot: 75157EV Exp. 06/01/2018 Lot: 75367EV, Exp. 06/01/2018 b.) 25 vial carton Lot: 75158EV; Exp. 06/01/2018

Distribution pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

drug · product 4 of 4

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

D-1049-2017
Recall number
D-1049-2017
Initiated
June 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Hospira a Pfizer Company
Quantity
21,436,700 5mL single dose vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

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

Distribution pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Field note

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