Exact FDA event identifier

Event 61918

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

Event summary

Timeline bucket: May 04, 2012
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hospira Inc.

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

9 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 9

0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045

D-611-2013

Recall number: D-611-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 2,137,660 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 2 of 9

70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07

D-612-2013

Recall number: D-612-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 14,706 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: 13-041-JT, Exp 1/14

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 3 of 9

0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02

D-613-2013

Recall number: D-613-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 136,584 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: 93-153-JT, Exp 9/12

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 4 of 9

5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045

D-614-2013

Recall number: D-614-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 267,288 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 5 of 9

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48

D-615-2013

Recall number: D-615-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 74,256 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: 11-161-JT, Exp 11/13

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 6 of 9

20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045

D-616-2013

Recall number: D-616-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 216,396 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 7 of 9

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

D-617-2013

Recall number: D-617-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 98,084 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lots #: 04-151-JT, 06-040-JT, Exp 4/13

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 8 of 9

1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08

D-618-2013

Recall number: D-618-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 40,988 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: 95-057-JT, Exp 11/12

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

drug · product 9 of 9

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045

D-619-2013

Recall number: D-619-2013
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 2,933,936 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information

Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12

Distribution pattern

Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia