The Recall Desk

FDA (Drugs) recall action 91712

AVEVA Drug Delivery Systems, Inc. recalled 2 products on 2023-03-22

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2023-03-22
Critical
0
Units
16,728

Why these products were recalled

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2023-03-22

    Buprenorphine Transdermal System Recalled for Failed Impurity Specifications

    AVEVA Drug Delivery Systems recalls nationwide batches of Buprenorphine Transdermal patches due to a degradation impurity exceeding acceptable limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-03-22

    Buprenorphine Transdermal System 20 mcg/hour Recalled for Specification Failure

    AVEVA Drug Delivery Systems recalls Buprenorphine Transdermal System 20 mcg/hour (Lot 51836) nationwide due to degradation product impurity exceeding specification limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05
    Category
    Distribution
    0 states