New England Compounding Center Recalls Hyaluronidase Vials Due to Sterility Concerns
New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is 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, FDA Class II recalls with potential for serious injury (implied by sterility failure in a medical product) or significant risk are rated as Severe (4), especially when no explicit 'no illness' statement is present to cap the score at 3.
Plain-English summary
New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials in 1 mL, 5 mL, and 10 mL sizes. The recall involves 10,865 vials distributed nationwide. The agency classification for this recall is Class II.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify which lot codes are affected, though the structured data indicates 'All lot codes'. No specific dates of distribution or manufacturing are provided in the source text.
Consumers and healthcare providers should stop using the recalled vials and contact the manufacturer or their supplier for instructions on return or replacement. The FDA has not reported specific illnesses or injuries associated with this recall in the provided text.
The recalled product
- Product
- Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Medication
- Affected units
- 10,865
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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