AtHome Medical Recalls Liquid Oxygen Due to GMP Deviations
AtHome Medical, Inc. is recalling 80 lbs of Oxygen Refrigerated Liquid USP due to a lack of standard operating procedures for testing out-of-specification products.
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 GMP deviation regarding documentation and testing procedures. There are no reported illnesses or injuries, and the hazard is procedural rather than a confirmed physical defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AtHome Medical, Inc. is recalling 80 lbs of Oxygen Refrigerated Liquid USP UN 1073. The product is prescription-only and was distributed in New Jersey. The specific lot number is 051017V1 with an expiration date of 5/11/17.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations. Specifically, the firm does not include a standard operating procedure (SOP) for testing for out-of-specification products. This documentation gap represents a quality control issue rather than a confirmed product defect or reported injury.
Consumers with this product should contact AtHome Medical, Inc. at 973-538-0485 for instructions on how to proceed. The company is located at 200 American Road, Morris Plains, NJ 07950.
The recalled product
- Product
- Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
- Manufacturer
- AtHome Medical, Inc.
- Category
- Drug — Liquid Oxygen
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 (2)
- B-06324027 (AHM #E040645) Lot #: 051017V1
- Exp. Date: 5/11/17
Distribution
Distributed in 1 state:
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