Multi-event September 2015 FDA Recall Drug by Praxair Inc.

This Multi-event Class III drug recall was voluntarily initiated by Praxair Inc. on September 16, 2015 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0782-2016 TERMINATED D-0783-2016 TERMINATED

Recall Number: D-0782-2016

Reason for Recall
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Initiated
09-16-2015
Reported
04-06-2016
Quantity
127 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72252
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Praxair 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-10-2016
Product Description About Product Description
Full technical description of the product.
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.

Batch or Lot Expiration Information

Lot# P411517501, P411517601, P411517701, P411518001, P411518101, P411518201, P411518202, P411518301, P411518701, P411518801, P411518901, P411519101, P411519401, P411519601, P411519602, P411519701, P411520101, P411520301, P411520401, P411520901, P411521001, P411521002, P411521101, P411521201, P411521501, P411521601, P411521701, P411521801, P411521901, P411522201, P411522401, P411522501, P411522901, P411523001, P411523101, P411523201, P411523301, P411523601, P411523701, P411523801, P411523901, P411524001, P411524301

Recall Number: D-0783-2016

Reason for Recall
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Initiated
09-16-2015
Reported
04-06-2016
Quantity
382 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72252
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Praxair 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-10-2016
Product Description About Product Description
Full technical description of the product.
UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

Batch or Lot Expiration Information

Lot# K411517501, K411517601, K411517701, K411518001, K411518101, K411518201, K411518202, K411518301, K411518302, K411518701, K411518801, K411518901, K411518902, K411519001, K411519101, K411519401, K411519501, K411519601, K411519602, K411519701, K411519801, K411520101, K411520201, K411520301, K411520302, K411520401, K411520901, K411521001, K411521002, K411521101, K411521102, K411521201, K411521501, K411521601, K411521602, K411521701, K411521702, K411521801, K411521901, K411522201, K411522301, K411522401, K411522501, K411523001, K411523101, K411523201, K411523202, K411523301, K411523601, K411523701, K411523801, K411523901, K411523902, K411524001, K411524301, K411524302, K411524401, K411522601, K411522901