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UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN...

FDA Recall #D-0783-2016 — Class III — September 16, 2015

Recall #D-0783-2016 Date: September 16, 2015 Classification: Class III Status: Terminated

Product Description

UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

Reason for Recall

CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Recalling Firm

Praxair Inc. — Danbury, CT

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

382 cylinders

Distribution

Nationwide

Code 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,

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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