Buprenorphine Transdermal System recall: Impurity Out of Spec
Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug…
Why was Buprenorphine Transdermal System recalled?
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 51836 Exp: 07/2023
- Product
- Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug…
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- Quantity
- 5,208 cartons
- Distribution
- Nationwide
- Recall date
- March 22, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)