The Recall Desk
ModerateFDA (Drugs)·D-0779-2016·Announced 2016-03-30

AGA Gas Recalls Bulk Liquid Oxygen Due to GMP Deviations

AGA Gas Inc is recalling 1,500 gallons of bulk liquid oxygen because the delivery trailer may not have met GMP requirements prior to filling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a voluntary precautionary measure regarding GMP compliance without reported illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

AGA Gas Inc is voluntarily recalling 1,500 gallons of Oxygen, USP, 99.0%, Bulk Cryogenic Liquid (NDC 33237-001-01). The recall is limited to Lot# 7931-O-V32-5330-5-1062.

The recall was initiated due to cGMP deviations, specifically because the trailer used for delivery may not have met Good Manufacturing Practice (GMP) requirements prior to being filled with the product. The affected product was delivered to Ohio.

Consumers and healthcare facilities that have received this specific lot of bulk liquid oxygen should stop using it and contact AGA Gas Inc or their supplier for instructions on return or disposal.

The recalled product

Product
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Manufacturer
AGA Gas Inc
Category
Drug — Bulk Liquid Oxygen
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot# 7931-O-V32-5330-5-1062

Distribution

Distributed in 1 state:

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