Saline 10% and 3% vials are recalled for sterility assurance concern
New England Compounding Center is recalling 54 vials of Saline 10% and 3% in 5 mL and 10 mL sizes because sterility could not be assured. The vials were distributed nationwide, and all lot codes are included.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source identifies an FDA Class II recall and a lack of assurance of sterility, which is a risk-of-harm issue. The source does not report an injury, so the High criterion for a risk-of-harm product without reported injury applies.
Plain-English summary
The recall covers 54 vials of Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center in Framingham, Massachusetts. All lot codes are included, and the product was distributed nationwide.
The stated reason is a lack of assurance of sterility.
The source does not provide a specific consumer action.
The recalled product
- Product
- Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Sterility assurance
- Hazard
- Affected units
- 54
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 17 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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