Multi-event March 2016 FDA Recall Drug by Hospira Inc.

This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on March 8, 2016 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0831-2016 TERMINATED D-0832-2016 TERMINATED D-0828-2016 TERMINATED D-0827-2016 TERMINATED D-0830-2016 TERMINATED D-0829-2016 TERMINATED

Recall Number: D-0831-2016

Reason for Recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Initiated
03-08-2016
Reported
04-27-2016
Quantity
22292 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73472
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.
US: Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

Batch or Lot Expiration Information

Lot# 52-031-JT, Exp 10/16

Recall Number: D-0832-2016

Reason for Recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Initiated
03-08-2016
Reported
04-27-2016
Quantity
81888 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73472
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.
US: Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

Batch or Lot Expiration Information

Lot# Lo# 53-006-JT, Exp 11/16

Recall Number: D-0828-2016

Reason for Recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Initiated
03-08-2016
Reported
04-27-2016
Quantity
4368 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73472
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.
US: Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9

Batch or Lot Expiration Information

Lot# 52-002-JT, Exp 04/17

Recall Number: D-0827-2016

Reason for Recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Initiated
03-08-2016
Reported
04-27-2016
Quantity
11256 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73472
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.
US: Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5

Batch or Lot Expiration Information

Lot# 48-010-JT, Exp 12/16

Recall Number: D-0830-2016

Reason for Recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Initiated
03-08-2016
Reported
04-27-2016
Quantity
1776 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73472
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.
US: Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5

Batch or Lot Expiration Information

Lot# 49-047-JT, Exp: 07/16

Recall Number: D-0829-2016

Reason for Recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Initiated
03-08-2016
Reported
04-27-2016
Quantity
552 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73472
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.
US: Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2

Batch or Lot Expiration Information

Lot# 52-114-JT, Exp 10/16