Fentanyl Buccal Tablets 400mcg missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.
What this means for you
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 for a labeling/documentation defect (missing or incorrect package insert) with no reported illnesses or injuries. The hazard is documentation-based rather than product contamination or efficacy failure.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling specific lots of Fentanyl Buccal Tablets, 400mcg (NDC 51862-636-28), distributed by Mayne Pharma. The recall affects 1,272 cartons distributed nationwide. The recall is due to incorrect or missing package inserts in the affected cartons.
Fentanyl Buccal Tablets are controlled substances used for pain management. Proper labeling and package inserts are important for safe medication use and administration.
Patients currently using affected cartons should contact their pharmacy or healthcare provider. Healthcare providers and pharmacies should identify affected lots using the lot numbers and expiration dates and quarantine affected product: Lot 100020351 (Exp 11/2024), Lot 100020522 (Exp 09/2024), and Lot 100026700 (Exp 11/2024). No illnesses or adverse events have been reported in connection with this recall.
The recalled product
- Product
- Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Controlled Substance
- Hazard
- Affected units
- 1,272
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 (5)
- Lot#: 100020351
- Exp 11/2024
- 100020522
- Exp 09/2024
- 100026700
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teva Pharmaceuticals USA 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.
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