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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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