Multi-event October 2014 FDA Recall Drug by Hospira Inc.

This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on October 14, 2014 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0282-2015 TERMINATED D-0284-2015 TERMINATED D-0280-2015 TERMINATED D-0279-2015 TERMINATED D-0278-2015 TERMINATED D-0285-2015 TERMINATED D-0277-2015 TERMINATED D-0283-2015 TERMINATED D-0286-2015 TERMINATED D-0287-2015 TERMINATED D-0281-2015 TERMINATED

Recall Number: D-0282-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
340,272 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Recall Number: D-0284-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
305,664 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Recall Number: D-0280-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
823,296 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Recall Number: D-0279-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
301,560 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the product.
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.

Batch or Lot Expiration Information

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

Recall Number: D-0278-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
836,460 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Recall Number: D-0285-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
16,487,040 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

Batch or Lot Expiration 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

Recall Number: D-0277-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
152,172 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Recall Number: D-0283-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
6,193,416 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the product.
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.

Batch or Lot Expiration 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

Recall Number: D-0286-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
784,920 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the product.
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

Batch or Lot Expiration 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

Recall Number: D-0287-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
153,504 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the product.
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.

Batch or Lot Expiration Information

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

Recall Number: D-0281-2015

Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Initiated
10-14-2014
Reported
12-03-2014
Quantity
275,448 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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