The Recall Desk
SevereFDA (Drugs)·D-0558-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

QuVa Pharma is recalling fentanyl 50 mcg/mL syringes because of potential glass particulate matter. The recall covers multiple lots 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. According to the rubric, an FDA Class II recall involving a significant hazard such as particulate matter in an injectable drug corresponds to a severity score of 4 (Severe).

Plain-English summary

QuVa Pharma, Inc. is recalling fentanyl 2750 mcg/55 mL (50 mcg/mL) 55 mL syringes, preservative free, prescription only. The recall is due to the presence of particulate matter, specifically the potential for glass particles in the fentanyl API.

The affected product is identified by NDC 70092-1100-50. The recall includes specific lots with expiration dates ranging from November 2019 to December 2019. The distribution pattern for these products is nationwide.

Healthcare providers and patients should check their inventory and medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or supplier for credit or replacement.

The recalled product

Product
fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Injectable
Hazard

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 (11)

  • Lots: 10029773 Exp. 11/17/2019
  • 10029821 Exp. 11/18/2019
  • 10030351 Exp. 11/21/2019
  • 10031014 Exp. 12/2/2019
  • 10030912 Exp. 12/2/2019
  • 10030569 Exp. 11/28/2019
  • 10030966 Exp. 12/3/2019
  • 10031796 Exp. 12/23/2019
  • 10031509 Exp. 12/17/2019
  • 10031067 Exp. 12/5/2019
  • 10031156 Exp. 12/16/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 recalled by QuVa Pharma, Inc. 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 27 products in this recall →

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Same hazard · particulate matter

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