New England Home Therapies Recalls Compounded Sterile Drugs for Sterility Concerns
New England Home Therapies is recalling all sterile drugs compounded between February 21 and 24, 2014, due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility in sterile drugs) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High due to the agency classification and nature of the defect.
Plain-English summary
New England Home Therapies, Inc. is recalling all sterile drugs compounded between February 21, 2014, and February 24, 2014. The recall involves 87 products with expiration dates between March 5, 2014, and March 10, 2014. The reason for the recall is a lack of assurance of sterility for these compounded products.
The affected products were distributed in the New England region of the United States. The source text does not specify the exact number of units recalled or report any illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the affected products and contact New England Home Therapies, Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- All sterile drugs compounded between 2/21/14 and 2/24/14.
- Manufacturer
- New England Home Therapies, Inc
- Category
- Drug — Compounded Sterile Drugs
- Hazard
- Affected units
- 87
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)
- Expiration dates between 3/5/14 and 3/10/14.
Distribution
Distribution scope not specified by the agency.
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