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.
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 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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