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Class II: temporary or reversible health riskTerminated

AGA Gas Oxygen Recall

Oxygen, USP, 99

AGA Gas Inc · Independence, OH

Risk level
Class II
Reported by FDA
Mar 30, 2016
Recall ID
D-0779-2016
Check your lot numberHow we source this data

Summary

AGA Gas recalled Oxygen starting Nov 29, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0779-2016 on Mar 30, 2016. Reason: cGMP Deviations; trailer may not have met GMP requirements prior to filling. Status: Terminated.

Why it was recalled

cGMP Deviations; trailer may not have met GMP requirements prior to filling

Product description

Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01

Lot numbers, UPCs & expiration codes

Lot# 7931-O-V32-5330-5-1062

Where it was sold

Product was delivered to Ohio

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0779-2016
Classification
Class II
Status
Terminated
Recall initiated
Nov 29, 2015
FDA report date
Mar 30, 2016
Quantity
1,500 gallons
Recall type
Voluntary: Firm initiated
Recalling firm
AGA Gas Inc

Original FDA data

Every field from FDA enforcement report D-0779-2016, exactly as published.

Show all FDA fields
City
Independence
State
OH
Status
Terminated
Country
United States
Event ID
72796
Address
6055 Rockside Woods Blvd
Code information
Lot# 7931-O-V32-5330-5-1062
Postal code
44131-2301
Report date
Mar 30, 2016
Product type
Drugs
Recall number
D-0779-2016
Classification
Class II
Recalling firm
AGA Gas Inc
Product quantity
1,500 gallons
Termination date
Dec 13, 2017
Reason for recall
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Voluntary / mandated
Voluntary: Firm initiated
Product description
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Distribution pattern
Product was delivered to Ohio
Recall initiation date
Nov 29, 2015
Initial firm notification
Letter
Center classification date
Mar 18, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0779-2016, published Mar 30, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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