The Recall Desk
HighFDA (Drugs)·D-124-2013·Announced 2013-01-09

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.

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 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
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 →