March 2015 FDA Recall Air by Matheson, Inc.
D-0423-2015 - Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
This Class III drug recall was voluntarily initiated by Matheson, Inc. on March 10, 2015 for the product Air. The FDA reported the reason for recall as failed impurities/degradation specification; out of specification results for carbon dioxide. The product was distributed in Michigan and Wisconsin and the recall is currently terminated.
Recall Number: D-0423-2015
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
03-10-2015
04-01-2015
137,880 cubic feet
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Matheson, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Michigan and Wisconsin
04-17-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20.
Batch or Lot Expiration Information
Lot# A)
Lot# : BAHC564281A, BAHC564281B, BAHC546288A, BAHC564288B, BAHC546288C, BAHC546288D, BAHC546288E, BAHC564307A, BAHC564314A, BAHC564329A. BAHC564329B, BAHC564329C, BAHC564329D, BAHC564329E, BAHC564344A, BAHC565005A, BAHC565006A, BAHC565013A, BAHC565015A, BAHC565015B, BAHC565015C, BAHC565015D, BAHC565029A, BAHC565035A. BAHC565035B, BAHC565035D; B)
Lot# : BAHC564282A, BAHC564296A, BAHC564303A, BAHC564344A, BAJC565016A, BAHC565034A, BAHC565043A, BAHC565054A; C)
Lot# : BAHC564269A, BAHC564275A, BAHC564282A, BAHC564288A, BAHC564296A, BAHC564303A, BAHC564308A, BAHC564317A, BAHC564324A, BAHC564329A, BAHC564338A, BAHC564344A, BAHC564351A, BAHC565016A, BAHC565020A, BAHC565028A, BAHC565043A, BAHC565054A; D)
Lot# : BAHC564365A; E)
Lot# : BAHC564269A, BAHC564275A, BAHC564279A, BAHC564282A, BAHC564290A, BAHC564296A, BAHC564303A, BAHC564308A, BAHC564317, BAHC564324A, BAHC564329A, BAHC564350A, BAHC564356A, BAHC564365A, BAHC565005A, BAHC565006A, BAHC565013A, BAHC565020A, BAHC565029A, BAHC565042A, BAHC565054A.
