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.
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 11
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information
Lot # 32-082-JT; Exp. 08/15
Distribution pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
drug · product 2 of 11
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information
Lot # 33-094-JT; Exp. 09/15 Lot # 35-028-JT; Exp. 11/15
Distribution pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
drug · product 4 of 11
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information
Lot # 34-134-JT Exp. 10/15 Lot # 34-166-JT Exp. 10/15
Distribution pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
drug · product 6 of 11
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information
Lot # 32-099-JT; Exp. 08/15 Lot # 32-103-JT; Exp. 08/15 Lot # 34-070-JT; Exp. 10/15 Lot # 34-086-JT; Exp. 10/15 Lot # 34-165-JT; Exp. 10/15 Lot # 35-085-JT; Exp. 11/15 Lot # 35-115-JT; Exp. 11/15 Lot # 35-121-JT; Exp. 11/15 Lot # 36-057-JT; Exp. 12/15
Distribution pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
drug · product 8 of 11
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information
Lot # 32-044-JT; Exp. 08/15 Lot # 32-072-JT; Exp. 08/15 Lot # 32-102-JT; Exp. 08/15 Lot # 33-028-JT; Exp. 09/15 Lot # 33-046-JT; Exp. 09/15 Lot # 33-049-JT; Exp. 09/15 Lot # 33-061-JT; Exp. 09/15 Lot # 33-085-JT; Exp. 09/15 Lot # 33-096-JT; Exp. 09/15 Lot # 33-101-JT; Exp. 09/15 Lot # 33-102-JT; Exp. 09/15 Lot # 34-016-JT; Exp. 10/15 Lot # 34-085-JT; Exp. 10/15 Lot # 34-122-JT; Exp. 10/15 Lot # 34-123-JT; Exp. 10/15 Lot # 35-026-JT; Exp. 11/15 Lot # 35-030-JT; Exp. 11/15 Lot # 35-067-JT; Exp. 11/15 Lot # 36-002-JT ;Exp. 12/15 Lot # 36-029-JT; Exp. 12/15 Lot # 36-049-JT; Exp. 12/15 Lot # 36-058-JT; Exp. 12/15 Lot # 36-103-JT; Exp. 12/15 Lot # 37-013-JT; Exp. 01/16
Distribution pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
drug · product 10 of 11
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information
Lot # 33-027-JT; Exp.09/15 Lot # 33-045-JT; Exp.09/15 Lot # 33-097-JT; Exp.09/15 Lot # 35-068-JT; Exp.11/15 Lot # 36-112-JT; Exp.12/15 Lot # 37-012-JT; Exp.01/15
Distribution pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
drug · product 11 of 11
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
