Sterile Products from New England Compounding Center Recalled Due to Sterility Concerns
New England Compounding Center is recalling all of its sterile products because the company cannot assure that the products are sterile.
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, which corresponds to a Severe rating under the provided rubric.
Plain-English summary
New England Compounding Center (NECC), based in Framingham, MA, is recalling all of its sterile products. This recall affects all lot codes of these products.
The recall was initiated because there is a lack of assurance regarding the sterility of the products. A complete list of the affected products is available on the manufacturer's website at www.neccrx.com.
These products were distributed nationwide within the United States and to Japan.
The recalled product
- Product
- All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
- Manufacturer
- New England Compounding Center
- Category
- Drug — Sterile Compounded Drugs
- 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)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by New England Compounding Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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