Hospira Inc.: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Agency Publication Date: November 25, 2014

Affected Products

Product: 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.

Lot # 32-082-JT; Exp. 08/15

Lot Numbers:

32-082-JT

Product: 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.

Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15

Lot Numbers:

34-017-JT

35-100-JT

Product: 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.

Lot # 33-094-JT; Exp. 09/15 Lot # 35-028-JT; Exp. 11/15

Lot Numbers:

33-094-JT

35-028-JT

Product: 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.

Lot # 33-095-JT; Exp. 09/15 Lot # 36-030-JT; Exp. 12/15

Lot Numbers:

33-095-JT

36-030-JT

Product: Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.

Lot # 34-134-JT Exp. 10/15 Lot # 34-166-JT Exp. 10/15

Lot Numbers:

34-134-JT

34-166-JT

Product: 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.

Lot # 32-104-JT; Exp. 08/15 Lot # 34-136-JT; Exp. 10/15 Lot # 36-092-JT; Exp. 12/15

Lot Numbers:

32-104-JT

34-136-JT

36-092-JT

Product: Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.

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

Lot Numbers:

32-099-JT

32-103-JT

34-070-JT

34-086-JT

34-165-JT

35-085-JT

35-115-JT

35-121-JT

36-057-JT

Product: 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.

Lot # 32-081-JT; Exp. 08/15 Lot # 34-115-JT; Exp. 10/15

Lot Numbers:

32-081-JT

34-115-JT

Product: 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

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

Lot Numbers:

32-044-JT

32-072-JT

32-102-JT

33-028-JT

33-046-JT

33-049-JT

33-061-JT

33-085-JT

33-096-JT

33-101-JT

33-102-JT

34-016-JT

34-085-JT

34-122-JT

34-123-JT

35-026-JT

35-030-JT

35-067-JT

36-002-JT

36-029-JT

36-049-JT

36-058-JT

36-103-JT

37-013-JT

Product: 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

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

Lot Numbers:

33-027-JT

33-045-JT

33-097-JT

35-068-JT

36-112-JT

37-012-JT

Product: Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.

Lot# 36-084-JT; Exp.12/15

Lot Numbers:

36-084-JT

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69494

Status: Resolved

Manufacturer: Hospira Inc.

Manufactured In: United States

Units Affected: 11 products (152,172 bags; 836,460 bags; 301,560 bags; 823,296 bags; 275,448 bags; 340,272 bags; 6,193,416 bags; 305,664 bags; 16,487,040 bags; 784,920 bags; 153,504 bags)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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.

Lot # 32-082-JT; Exp. 08/15

Lot Numbers:

32-082-JT

Product: 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.

Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15

Lot Numbers:

34-017-JT

35-100-JT

Product: 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.

Lot # 33-094-JT; Exp. 09/15 Lot # 35-028-JT; Exp. 11/15

Lot Numbers:

33-094-JT

35-028-JT

Product: 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.

Lot # 33-095-JT; Exp. 09/15 Lot # 36-030-JT; Exp. 12/15

Lot Numbers:

33-095-JT

36-030-JT

Product: Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.

Lot # 34-134-JT Exp. 10/15 Lot # 34-166-JT Exp. 10/15

Lot Numbers:

34-134-JT

34-166-JT

Product: 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.

Lot # 32-104-JT; Exp. 08/15 Lot # 34-136-JT; Exp. 10/15 Lot # 36-092-JT; Exp. 12/15

Lot Numbers:

32-104-JT

34-136-JT

36-092-JT

Product: Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.

Lot Numbers:

32-099-JT

32-103-JT

34-070-JT

34-086-JT

34-165-JT

35-085-JT

35-115-JT

35-121-JT

36-057-JT

Product: 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.

Lot # 32-081-JT; Exp. 08/15 Lot # 34-115-JT; Exp. 10/15

Lot Numbers:

32-081-JT

34-115-JT

Product: 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

Lot Numbers:

32-044-JT

32-072-JT

32-102-JT

33-028-JT

33-046-JT

33-049-JT

33-061-JT

33-085-JT

33-096-JT

33-101-JT

33-102-JT

34-016-JT

34-085-JT

34-122-JT

34-123-JT

35-026-JT

35-030-JT

35-067-JT

36-002-JT

36-029-JT

36-049-JT

36-058-JT

36-103-JT

37-013-JT

Product: 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

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

Lot Numbers:

33-027-JT

33-045-JT

33-097-JT

35-068-JT

36-112-JT

37-012-JT

Product: Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.

Lot# 36-084-JT; Exp.12/15

Lot Numbers:

36-084-JT

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69494

Status: Resolved

Manufacturer: Hospira Inc.

Manufactured In: United States

Units Affected: 11 products (152,172 bags; 836,460 bags; 301,560 bags; 823,296 bags; 275,448 bags; 340,272 bags; 6,193,416 bags; 305,664 bags; 16,487,040 bags; 784,920 bags; 153,504 bags)