New England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns
New England Compounding Center is recalling specific Triamcinolone vials nationwide because the company cannot guarantee the products are sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involves a risk-of-harm product (sterility issue in injectable medication) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
New England Compounding Center, located in Framingham, Massachusetts, is recalling Triamcinolone 10 mg/mL P, 40 mg/mL P, 40 mg/mL PF, and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials. The recall covers 56,655 vials distributed nationwide under all lot codes.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any specific illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions on how to handle or return the product.
The recalled product
- Product
- Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Steroids
- Hazard
- Affected units
- 56,655
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.
See all 17 products in this recall →Related recalls
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