Teva Recalls Buprenorphine Transdermal Patches for Stability Failures
Teva Pharmaceuticals USA is recalling Buprenorphine Transdermal Systems because they failed stability specifications for release rate.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The failure is a stability specification issue (release rate) rather than a contamination or mislabeling of a high-risk allergen, fitting the Moderate category for a voluntary precautionary recall of a prescription drug.
Plain-English summary
Teva Pharmaceuticals USA is recalling Buprenorphine Transdermal Systems, 5 mcg/hour, manufactured by 3M Drug Delivery Systems. The recall involves 32,543 cartons of the prescription medication, which were distributed nationwide in the U.S. and Puerto Rico.
The recall was initiated because the product failed stability specifications, specifically showing below-specification results for the buprenorphine release rate. The affected lots are #190017 (exp. 02/2021) and #190161 (exp. 08/2021).
Patients and healthcare providers should stop using the recalled patches and contact their healthcare provider for alternative treatment options. The product is available by prescription only.
The recalled product
- Product
- BUPRENORPHINE (BUPRENORPHINE)
- Brand
- BUPRENORPHINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Transdermal Patch
- Affected units
- 32,543
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 (4)
- Lot # 190017
- exp. 02/2021
- 190161
- exp. 08/2021
Distribution
Distributed nationwide across the United States.
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