The Recall Desk

FDA (Drugs) recall action 84263

QuVa Pharma, Inc. recalled 27 products on 2019-12-11

The FDA (Drugs) publishes a recall like this one as 27 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 27 pages.

Products
27
Announced
2019-12-11
Critical
0
Units
—

Why these products were recalled

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

The agency’s own wording, quoted from the enforcement report.

26–27 of 27

  • HighFDA (Drugs)··2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl syringes because they may contain glass particulate matter.

    Product
    fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-12-11

    QuVa Pharma Recalls Fentanyl Injection Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 100 mcg/2 mL injections because of potential glass particulate matter. The recall covers specific lots distributed nationwide.

    Product
    fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
    Category
    Distribution
    0 states