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

  • SevereFDA (Drugs)··2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.

    Product
    fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-12-11

    QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates

    QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
    Category
    Distribution
    0 states