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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

AVEVA Drug Delivery Systems, Inc. 2023-03-22 Health moderate FDA
Health · FDA · Recall #FDA-D-0465-2023

Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of… Recall

Issued March 22, 2023 · AVEVA Drug Delivery Systems, Inc.

In March 2023, AVEVA Drug Delivery Systems, Inc. recalled the Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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

What you should do

  1. 1 Stop using Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact AVEVA Drug Delivery Systems, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
AVEVA Drug Delivery Systems, Inc.
Category
Health
Recall date
March 22, 2023
Units affected
Not reported
Sold at
Nationwide
Recall number
FDA-D-0465-2023
Made in
United States
Issuing agency
FDA

In context

  • AVEVA Drug Delivery Systems, Inc. has 2 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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