The Recall Desk
SevereFDA (Drugs)·D-117-2013·Announced 2013-01-09

New England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns

New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.

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 severity score under the rubric, particularly given the risk of infection associated with non-sterile medical products.

Plain-English summary

New England Compounding Center, located in Framingham, MA, is recalling 165 vials of Glycerin 100% PF in 1mL, 2 mL, and 5 mL sizes. The recall was initiated because the manufacturer could not ensure the sterility of the product.

The affected vials were distributed nationwide. The recall covers all lot codes for this specific product.

Consumers and healthcare providers should stop using the recalled vials and contact the manufacturer or their supplier for further instructions or a refund.

The recalled product

Product
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Affected units
165

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 →