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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is a degradation impurity that exceeded specifications during stability testing, constituting a precautionary recall with lower likelihood of adverse health consequences.
Plain-English summary
AVEVA Drug Delivery Systems is recalling Buprenorphine Transdermal System 10 mcg/hour patches distributed nationwide. The recall affects 11,520 cartons with Lot 51835 and expiration date June 2023.
The product failed quality specifications during stability testing. Testing at the 18-month stability timepoint identified the related substance 10-hydroxy buprenorphine N-Oxide at levels exceeding acceptable limits.
Patients currently using buprenorphine patches from this lot should contact their healthcare provider or pharmacist.
The recalled product
- 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
- Manufacturer
- AVEVA Drug Delivery Systems, Inc.
- Category
- Drug — Transdermal Patch
- Affected units
- 11,520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot#: 51835 Exp: 06/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by AVEVA Drug Delivery Systems, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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